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CompletedNCT02434328HARRIERUpdated Jan 16, 2025Results posted

Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

A Phase 3 interventional study of Brolucizumab ophthalmic solution and Aflibercept ophthalmic solution in Neovascular Age-Related Macular Degeneration and Choroidal Neovascularization, sponsored by Alcon Research. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,048
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Read the detailed description

Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.

Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.

Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.

Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).

02

Conditions studied

  • Neovascular Age-Related Macular Degeneration
  • Choroidal Neovascularization

Keywords

  • AMD
  • CNV
  • IVT
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Provide written informed consent;
  • Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening;
  • Total area of CNV > 50% of the total lesion area in the study eye at Screening;
  • Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
  • Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Key Exclusion Criteria:

  • Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
  • Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening;
  • Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening;
  • Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
  • Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
  • Pregnant or nursing women; women of child-bearing potential;
  • Stroke or myocardial infarction in the 6-month period prior to Baseline.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,048 participants (actual)

Study arms

  • Experimental
    Brolucizumab 6 mg

    Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit

    Drug: Brolucizumab ophthalmic solution

  • Active comparator
    Aflibercept 2 mg

    Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit

    Drug: Aflibercept ophthalmic solution

Interventions

  • DrugBrolucizumab ophthalmic solution

    Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose

    Also known as: RTH258

  • DrugAflibercept ophthalmic solution

    Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose

    Also known as: EYLEA®

05

What researchers measure

Primary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Week 48

Secondary outcomes

  1. Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 36, 40, 44, 48

  2. Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48

    Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

    Time frame: Weeks 16, 20, 28, 32, 40, 44, 48

  3. Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)

    Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

    Time frame: Weeks 16, 20, 28, 32, 40, 44, 48

  4. Proportion of Subjects With Positive q12 Treatment Status up to Week 96

    Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

    Time frame: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96

  5. Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)

    Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

    Time frame: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96

  6. Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  7. Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  8. Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  9. Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 84, 88, 92, 96

  10. Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  11. Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  12. Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  13. Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  14. Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  15. Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  16. Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye

    BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  17. Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye

    CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  18. Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye

    CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 36, 40, 44, 48

  19. Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye

    CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 84, 88, 92, 96

  20. Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye

    CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  21. Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye

    CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 12, 48, 96

  22. Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye

    CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  23. Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye

    Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  24. Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye

    Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  25. Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye

    Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  26. Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye

    Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96

  27. Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye

    A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.

    Time frame: Week 16

  28. Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96

    The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.

    Time frame: Baseline, Weeks 24, 48, 72, 96

  29. Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)

    Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point.

    Time frame: Week 48

  30. Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye

    Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 12, 48, 96

  31. Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye

    Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

    Time frame: Baseline, Weeks 12, 48, 96

06

Results

Posted Oct 31, 2019

Participant flow

Subjects were recruited from investigative sites located in Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, South Korea, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, UK, and Vietnam.

Participant flow — Overall Study
MilestoneBrolucizumab 6 mgAflibercept 2 mg
Started372371
Randomized and treated370369
Completed342329
Not completed3042
Withdrew: Adverse event94
Withdrew: Lack of efficacy02
Withdrew: Physician decision01
Withdrew: Withdrawal by subject1221
Withdrew: Death47
Withdrew: Lost to follow-up16
Withdrew: Other41

Outcome measures

PrimaryChange From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Week 48
Reported as:
Mean · letters
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye6.9 ± 11.477.6 ± 12.47
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · p = <0.0001 (1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.) · Least squares mean difference: -0.7 · 95% CI -2.4 to 1.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 36, 40, 44, 48
Reported as:
Mean · letters
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye6.6 ± 11.107.7 ± 11.81
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · p = 0.0003 (1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.) · Least squares mean difference: -1.2 · 95% CI -2.8 to 0.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryProportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48

Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

Time frame:
Weeks 16, 20, 28, 32, 40, 44, 48
Reported as:
Number · proportion of subjects
Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48
proportion of subjectsBrolucizumab 6 mg
Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 480.5101 (0.4567 to 0.5610)
SecondaryProportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)

Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

Time frame:
Weeks 16, 20, 28, 32, 40, 44, 48
Reported as:
Number · proportion of subjects
Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)
proportion of subjectsBrolucizumab 6 mg
Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)0.8170 (0.7582 to 0.8629)
SecondaryProportion of Subjects With Positive q12 Treatment Status up to Week 96

Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

Time frame:
Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Reported as:
Number · proportion of subjects
Proportion of Subjects With Positive q12 Treatment Status up to Week 96
proportion of subjectsBrolucizumab 6 mg
Proportion of Subjects With Positive q12 Treatment Status up to Week 960.3856 (0.3336 to 0.4372)
SecondaryProportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)

Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.

Time frame:
Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Reported as:
Number · proportion of subjects
Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)
proportion of subjectsBrolucizumab 6 mg
Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)0.6170 (0.5465 to 0.6799)
SecondaryChange From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · letters
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 43.7 ± 7.034.7 ± 7.62
Change from baseline at Week 85.0 ± 8.166.0 ± 9.32
Change from baseline at Week 125.4 ± 9.356.4 ± 10.14
Change from baseline at Week 165.4 ± 9.656.3 ± 10.46
Change from baseline at Week 205.4 ± 10.426.9 ± 10.66
Change from baseline at Week 245.8 ± 10.766.7 ± 11.17
Change from baseline at Week 286.3 ± 10.977.4 ± 11.86
Change from baseline at Week 326.5 ± 10.927.3 ± 11.44
Change from baseline at Week 366.4 ± 11.327.6 ± 11.99
Change from baseline at Week 406.4 ± 11.667.6 ± 11.85
Change from baseline at Week 446.5 ± 11.518.0 ± 12.28
Change from baseline at Week 486.9 ± 11.477.6 ± 12.47
Change from baseline at Week 526.8 ± 12.037.4 ± 12.91
Change from baseline at Week 566.6 ± 12.437.2 ± 13.04
Change from baseline at Week 606.5 ± 12.237.4 ± 13.49
Change from baseline at Week 646.5 ± 12.517.2 ± 13.79
Change from baseline at Week 686.5 ± 12.227.1 ± 14.29
Change from baseline at Week 726.1 ± 13.326.9 ± 13.74
Change from baseline at Week 766.3 ± 13.446.8 ± 13.80
Change from baseline at Week 806.4 ± 13.436.6 ± 13.97
Change from baseline at Week 845.8 ± 13.766.7 ± 14.04
Change from baseline at Week 886.3 ± 13.406.9 ± 14.02
Change from baseline at Week 926.1 ± 13.856.5 ± 14.29
Change from baseline at Week 966.1 ± 14.066.6 ± 14.55
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.0 · 95% CI -2.0 to 0.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.0 · 95% CI -2.2 to 0.2Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.0 · 95% CI -2.4 to 0.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.9 · 95% CI -2.3 to 0.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.5 · 95% CI -3.0 to 0.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.9 · 95% CI -2.5 to 0.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.1 · 95% CI -2.7 to 0.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.9 · 95% CI -2.5 to 0.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.2 · 95% CI -2.9 to 0.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.2 · 95% CI -2.9 to 0.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.6 · 95% CI -3.2 to 0.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.7 · 95% CI -2.4 to 1.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.7 · 95% CI -2.5 to 1.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.7 · 95% CI -2.5 to 1.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.8 · 95% CI -2.7 to 1.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.7 · 95% CI -2.5 to 1.2Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.7 · 95% CI -2.5 to 1.2Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.9 · 95% CI -2.8 to 1.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.5 · 95% CI -2.5 to 1.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.2 · 95% CI -2.1 to 1.8Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.9 · 95% CI -2.9 to 1.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.6 · 95% CI -2.6 to 1.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.4 · 95% CI -2.4 to 1.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.4 · 95% CI -2.5 to 1.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · letters
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline over the period Week 4 to 485.8 ± 9.116.9 ± 10.11
Change from baseline over the period Week 4 to 966.1 ± 10.426.9 ± 11.41
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.1 · 95% CI -2.4 to 0.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.8 · 95% CI -2.4 to 0.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · letters
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline over the period Week 12 to 486.1 ± 9.917.2 ± 10.77
Change from baseline over the period Week 12 to 966.2 ± 10.977.0 ± 11.88
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -1.1 · 95% CI -2.5 to 0.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.8 · 95% CI -2.4 to 0.8Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.
SecondaryAverage Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 84, 88, 92, 96
Reported as:
Mean · letters
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye
lettersBrolucizumab 6 mgAflibercept 2 mg
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye6.1 ± 13.516.7 ± 13.96
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.6 · 95% CI -2.5 to 1.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryPercentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 47.6 (5.1 to 10.8)8.9 (6.2 to 12.3)
Change from baseline at Week 813.8 (10.4 to 17.7)18.2 (14.4 to 22.5)
Change from baseline at Week 1216.5 (12.9 to 20.7)21.4 (17.3 to 26.0)
Change from baseline at Week 1620.0 (16.0 to 24.4)22.2 (18.1 to 26.8)
Change from baseline at Week 2020.5 (16.5 to 25.0)23.6 (19.3 to 28.2)
Change from baseline at Week 2423.8 (19.5 to 28.5)22.8 (18.6 to 27.4)
Change from baseline at Week 2823.8 (19.5 to 28.5)27.4 (22.9 to 32.2)
Change from baseline at Week 3225.4 (21.0 to 30.2)28.7 (24.2 to 33.6)
Change from baseline at Week 3626.2 (21.8 to 31.0)30.9 (26.2 to 35.9)
Change from baseline at Week 4027.0 (22.6 to 31.9)31.4 (26.7 to 36.4)
Change from baseline at Week 4426.8 (22.3 to 31.6)31.2 (26.5 to 36.2)
Change from baseline at Week 4829.5 (24.9 to 34.4)29.8 (25.2 to 34.8)
Change from baseline at Week 5230.3 (25.6 to 35.2)30.6 (26.0 to 35.6)
Change from baseline at Week 5629.7 (25.1 to 34.7)30.6 (26.0 to 35.6)
Change from baseline at Week 6028.6 (24.1 to 33.5)30.6 (26.0 to 35.6)
Change from baseline at Week 6429.7 (25.1 to 34.7)30.9 (26.2 to 35.9)
Change from baseline at Week 6828.9 (24.3 to 33.8)32.2 (27.5 to 37.3)
Change from baseline at Week 7227.6 (23.1 to 32.4)31.4 (26.7 to 36.4)
Change from baseline at Week 7628.4 (23.8 to 33.3)30.6 (26.0 to 35.6)
Change from baseline at Week 8028.1 (23.6 to 33.0)30.4 (25.7 to 35.3)
Change from baseline at Week 8427.6 (23.1 to 32.4)31.2 (26.5 to 36.2)
Change from baseline at Week 8827.6 (23.1 to 32.4)33.1 (28.3 to 38.1)
Change from baseline at Week 9229.5 (24.9 to 34.4)30.9 (26.2 to 35.9)
Change from baseline at Week 9629.2 (24.6 to 34.1)31.4 (26.7 to 36.4)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.3 · 95% CI -5.1 to 2.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.3 · 95% CI -9.5 to 1.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.0 · 95% CI -10.5 to 0.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.3 · 95% CI -8.4 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.1 · 95% CI -8.8 to 2.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -5.2 to 6.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.7 · 95% CI -9.9 to 2.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.6 · 95% CI -10.5 to 2.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.9 · 95% CI -11.6 to 1.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.7 · 95% CI -11.5 to 1.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.6 · 95% CI -11.3 to 1.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.6 · 95% CI -7.1 to 5.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.6 · 95% CI -7.0 to 5.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.1 · 95% CI -7.7 to 5.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.2 · 95% CI -8.3 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -7.9 to 5.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.5 · 95% CI -9.9 to 3.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.1 · 95% CI -10.2 to 2.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.4 · 95% CI -8.8 to 4.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.6 · 95% CI -9.0 to 3.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.8 · 95% CI -9.9 to 2.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.8 · 95% CI -11.8 to 0.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.7 · 95% CI -7.9 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.4 · 95% CI -8.8 to 4.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 420.0 (16.0 to 24.4)22.2 (18.1 to 26.8)
Change from baseline at Week 826.8 (22.3 to 31.6)32.8 (28.0 to 37.8)
Change from baseline at Week 1232.4 (27.7 to 37.5)36.0 (31.1 to 41.2)
Change from baseline at Week 1636.5 (31.6 to 41.6)36.9 (31.9 to 42.0)
Change from baseline at Week 2033.8 (29.0 to 38.9)38.2 (33.2 to 43.4)
Change from baseline at Week 2435.7 (30.8 to 40.8)39.3 (34.3 to 44.5)
Change from baseline at Week 2840.3 (35.2 to 45.5)42.5 (37.4 to 47.8)
Change from baseline at Week 3241.1 (36.0 to 46.3)43.4 (38.2 to 48.6)
Change from baseline at Week 3640.3 (35.2 to 45.5)45.5 (40.4 to 50.8)
Change from baseline at Week 4043.5 (38.4 to 48.7)46.3 (41.2 to 51.6)
Change from baseline at Week 4442.4 (37.3 to 47.6)45.3 (40.1 to 50.5)
Change from baseline at Week 4844.1 (38.9 to 49.3)45.8 (40.6 to 51.0)
Change from baseline at Week 5244.9 (39.7 to 50.1)45.8 (40.6 to 51.0)
Change from baseline at Week 5643.0 (37.9 to 48.2)45.5 (40.4 to 50.8)
Change from baseline at Week 6042.2 (37.1 to 47.4)44.7 (39.6 to 49.9)
Change from baseline at Week 6444.3 (39.2 to 49.5)45.8 (40.6 to 51.0)
Change from baseline at Week 6843.5 (38.4 to 48.7)45.0 (39.8 to 50.2)
Change from baseline at Week 7241.1 (36.0 to 46.3)44.4 (39.3 to 49.7)
Change from baseline at Week 7645.4 (40.3 to 50.6)44.7 (39.6 to 49.9)
Change from baseline at Week 8043.8 (38.7 to 49.0)44.2 (39.0 to 49.4)
Change from baseline at Week 8440.8 (35.8 to 46.0)44.2 (39.0 to 49.4)
Change from baseline at Week 8843.2 (38.1 to 48.5)45.5 (40.4 to 50.8)
Change from baseline at Week 9245.4 (40.3 to 50.6)43.4 (38.2 to 48.6)
Change from baseline at Week 9645.1 (40.0 to 50.4)45.0 (39.8 to 50.2)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.1 · 95% CI -7.6 to 3.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.0 · 95% CI -13.0 to 0.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.8 · 95% CI -10.1 to 2.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -7.3 to 6.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.6 · 95% CI -11.2 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.7 · 95% CI -10.7 to 3.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.4 · 95% CI -9.6 to 4.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.6 · 95% CI -9.4 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.4 · 95% CI -12.1 to 1.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.1 · 95% CI -9.9 to 3.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.0 · 95% CI -10.3 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.9 · 95% CI -8.7 to 4.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.3 · 95% CI -8.0 to 5.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.8 · 95% CI -9.8 to 4.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.8 · 95% CI -9.6 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.7 · 95% CI -8.8 to 5.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.7 · 95% CI -8.4 to 5.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.6 · 95% CI -10.4 to 2.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.5 · 95% CI -6.5 to 7.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -7.5 to 6.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.5 · 95% CI -10.4 to 3.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.5 · 95% CI -9.6 to 3.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.9 · 95% CI -5.0 to 8.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.1 · 95% CI -7.0 to 6.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 441.6 (36.5 to 46.8)45.3 (40.1 to 50.5)
Change from baseline at Week 850.0 (44.8 to 55.2)53.1 (47.9 to 58.3)
Change from baseline at Week 1255.1 (49.9 to 60.3)58.5 (53.3 to 63.6)
Change from baseline at Week 1655.4 (50.2 to 60.5)56.6 (51.4 to 61.8)
Change from baseline at Week 2055.9 (50.7 to 61.1)61.0 (55.8 to 66.0)
Change from baseline at Week 2458.1 (52.9 to 63.2)61.0 (55.8 to 66.0)
Change from baseline at Week 2860.0 (54.8 to 65.0)65.6 (60.5 to 70.4)
Change from baseline at Week 3264.1 (58.9 to 68.9)65.6 (60.5 to 70.4)
Change from baseline at Week 3663.2 (58.1 to 68.2)65.3 (60.2 to 70.2)
Change from baseline at Week 4063.0 (57.8 to 67.9)64.0 (58.8 to 68.9)
Change from baseline at Week 4464.6 (59.5 to 69.5)65.9 (60.8 to 70.7)
Change from baseline at Week 4864.6 (59.5 to 69.5)64.5 (59.4 to 69.4)
Change from baseline at Week 5263.0 (57.8 to 67.9)65.3 (60.2 to 70.2)
Change from baseline at Week 5662.7 (57.6 to 67.6)64.2 (59.1 to 69.1)
Change from baseline at Week 6062.2 (57.0 to 67.1)62.6 (57.4 to 67.6)
Change from baseline at Week 6465.7 (60.6 to 70.5)63.1 (58.0 to 68.1)
Change from baseline at Week 6862.2 (57.0 to 67.1)63.4 (58.3 to 68.3)
Change from baseline at Week 7263.0 (57.8 to 67.9)61.5 (56.3 to 66.5)
Change from baseline at Week 7663.8 (58.7 to 68.7)61.5 (56.3 to 66.5)
Change from baseline at Week 8065.1 (60.0 to 70.0)60.7 (55.5 to 65.7)
Change from baseline at Week 8461.9 (56.7 to 66.9)64.2 (59.1 to 69.1)
Change from baseline at Week 8863.2 (58.1 to 68.2)62.1 (56.9 to 67.0)
Change from baseline at Week 9264.6 (59.5 to 69.5)60.7 (55.5 to 65.7)
Change from baseline at Week 9664.1 (58.9 to 68.9)60.7 (55.5 to 65.7)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.5 · 95% CI -10.4 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.2 · 95% CI -10.2 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.7 · 95% CI -10.7 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -8.4 to 5.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.3 · 95% CI -12.3 to 1.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.2 · 95% CI -9.9 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.9 · 95% CI -12.8 to 0.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.9 · 95% CI -8.2 to 4.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.3 · 95% CI -9.2 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.3 · 95% CI -8.2 to 5.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.5 · 95% CI -8.5 to 5.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.2 · 95% CI -7.4 to 6.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.7 · 95% CI -9.8 to 4.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.7 · 95% CI -8.6 to 4.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -7.8 to 6.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.3 · 95% CI -4.5 to 9.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.5 · 95% CI -8.6 to 4.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.1 · 95% CI -5.8 to 7.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.0 · 95% CI -5.1 to 8.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 4.2 · 95% CI -2.8 to 10.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.7 · 95% CI -9.3 to 4.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -6.1 to 7.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.7 · 95% CI -3.0 to 10.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.1 · 95% CI -3.9 to 10.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 41.1 (0.3 to 2.7)1.1 (0.3 to 2.8)
Change from baseline at Week 81.1 (0.3 to 2.7)1.6 (0.6 to 3.5)
Change from baseline at Week 121.9 (0.8 to 3.9)1.9 (0.8 to 3.9)
Change from baseline at Week 162.2 (0.9 to 4.2)2.2 (0.9 to 4.2)
Change from baseline at Week 203.5 (1.9 to 5.9)3.0 (1.5 to 5.3)
Change from baseline at Week 242.7 (1.3 to 4.9)3.3 (1.7 to 5.6)
Change from baseline at Week 283.0 (1.5 to 5.3)3.5 (1.9 to 5.9)
Change from baseline at Week 323.2 (1.7 to 5.6)3.8 (2.1 to 6.3)
Change from baseline at Week 363.8 (2.1 to 6.3)3.5 (1.9 to 5.9)
Change from baseline at Week 405.4 (3.3 to 8.2)4.3 (2.5 to 6.9)
Change from baseline at Week 444.6 (2.7 to 7.3)4.6 (2.7 to 7.3)
Change from baseline at Week 483.8 (2.1 to 6.3)4.9 (2.9 to 7.6)
Change from baseline at Week 524.6 (2.7 to 7.3)5.7 (3.6 to 8.6)
Change from baseline at Week 565.9 (3.8 to 8.9)5.4 (3.3 to 8.2)
Change from baseline at Week 606.2 (4.0 to 9.2)5.7 (3.6 to 8.6)
Change from baseline at Week 646.8 (4.4 to 9.8)6.2 (4.0 to 9.2)
Change from baseline at Week 685.4 (3.3 to 8.2)6.5 (4.2 to 9.5)
Change from baseline at Week 727.3 (4.9 to 10.4)6.5 (4.2 to 9.5)
Change from baseline at Week 766.8 (4.4 to 9.8)6.2 (4.0 to 9.2)
Change from baseline at Week 807.0 (4.6 to 10.1)6.2 (4.0 to 9.2)
Change from baseline at Week 847.3 (4.9 to 10.4)7.3 (4.9 to 10.5)
Change from baseline at Week 886.8 (4.4 to 9.8)7.0 (4.7 to 10.2)
Change from baseline at Week 927.0 (4.6 to 10.1)7.6 (5.1 to 10.8)
Change from baseline at Week 967.0 (4.6 to 10.1)7.6 (5.1 to 10.8)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.0 · 95% CI -1.6 to 1.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.6 · 95% CI -2.3 to 1.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.0 · 95% CI -1.9 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.0 · 95% CI -2.1 to 2.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.6 · 95% CI -2.0 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -3.0 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -3.0 to 2.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -3.2 to 2.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.4 · 95% CI -2.3 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -1.7 to 4.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.1 · 95% CI -2.7 to 3.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.0 · 95% CI -3.9 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.0 · 95% CI -4.3 to 2.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.6 · 95% CI -2.8 to 3.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.6 · 95% CI -2.5 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.7 · 95% CI -2.7 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.9 · 95% CI -4.2 to 2.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -2.5 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.7 · 95% CI -2.5 to 4.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -2.4 to 4.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.2 · 95% CI -3.1 to 4.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.2 · 95% CI -3.5 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.4 · 95% CI -3.8 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.4 · 95% CI -3.8 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 41.9 (0.8 to 3.9)2.4 (1.1 to 4.6)
Change from baseline at Week 82.2 (0.9 to 4.2)2.2 (0.9 to 4.2)
Change from baseline at Week 122.7 (1.3 to 4.9)3.0 (1.5 to 5.3)
Change from baseline at Week 163.8 (2.1 to 6.3)5.1 (3.1 to 7.9)
Change from baseline at Week 205.9 (3.8 to 8.9)4.6 (2.7 to 7.3)
Change from baseline at Week 245.1 (3.1 to 7.9)6.0 (3.8 to 8.9)
Change from baseline at Week 285.9 (3.8 to 8.9)5.7 (3.6 to 8.6)
Change from baseline at Week 325.9 (3.8 to 8.9)6.2 (4.0 to 9.2)
Change from baseline at Week 366.5 (4.2 to 9.5)6.2 (4.0 to 9.2)
Change from baseline at Week 407.0 (4.6 to 10.1)6.0 (3.8 to 8.9)
Change from baseline at Week 448.6 (6.0 to 12.0)6.2 (4.0 to 9.2)
Change from baseline at Week 486.8 (4.4 to 9.8)7.3 (4.9 to 10.5)
Change from baseline at Week 528.1 (5.5 to 11.4)7.3 (4.9 to 10.5)
Change from baseline at Week 569.2 (6.4 to 12.6)8.1 (5.6 to 11.4)
Change from baseline at Week 608.1 (5.5 to 11.4)7.3 (4.9 to 10.5)
Change from baseline at Week 648.4 (5.8 to 11.7)8.7 (6.0 to 12.0)
Change from baseline at Week 687.6 (5.1 to 10.8)8.4 (5.8 to 11.7)
Change from baseline at Week 727.8 (5.3 to 11.1)8.1 (5.6 to 11.4)
Change from baseline at Week 769.5 (6.7 to 12.9)9.2 (6.5 to 12.6)
Change from baseline at Week 809.2 (6.4 to 12.6)10.0 (7.2 to 13.6)
Change from baseline at Week 849.5 (6.7 to 12.9)9.5 (6.7 to 12.9)
Change from baseline at Week 888.9 (6.2 to 12.3)9.8 (6.9 to 13.3)
Change from baseline at Week 929.2 (6.4 to 12.6)11.1 (8.1 to 14.8)
Change from baseline at Week 969.2 (6.4 to 12.6)10.3 (7.4 to 13.9)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -2.6 to 1.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.0 · 95% CI -2.2 to 2.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.3 · 95% CI -2.8 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -4.4 to 1.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.4 · 95% CI -1.7 to 4.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -3.9 to 2.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.3 · 95% CI -3.2 to 3.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.1 · 95% CI -3.8 to 3.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.3 · 95% CI -3.0 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -2.4 to 5.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.5 · 95% CI -1.1 to 6.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.4 · 95% CI -4.0 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -2.8 to 4.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -2.8 to 5.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference of proportions: 1.0 · 95% CI -2.6 to 4.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.1 · 95% CI -4.0 to 4.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.6 · 95% CI -4.2 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.1 · 95% CI -4.0 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.4 · 95% CI -3.5 to 4.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -4.5 to 3.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.2 · 95% CI -3.6 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -4.5 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.8 · 95% CI -5.7 to 2.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.0 · 95% CI -4.9 to 3.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 46.2 (4.0 to 9.2)6.5 (4.2 to 9.5)
Change from baseline at Week 87.8 (5.3 to 11.1)8.4 (5.8 to 11.7)
Change from baseline at Week 128.4 (5.8 to 11.7)9.5 (6.7 to 12.9)
Change from baseline at Week 1610.8 (7.8 to 14.4)8.9 (6.2 to 12.3)
Change from baseline at Week 2011.6 (8.5 to 15.3)8.1 (5.6 to 11.4)
Change from baseline at Week 2413.0 (9.7 to 16.8)10.0 (7.2 to 13.6)
Change from baseline at Week 2811.4 (8.3 to 15.0)8.9 (6.2 to 12.3)
Change from baseline at Week 3212.2 (9.0 to 15.9)11.1 (8.1 to 14.8)
Change from baseline at Week 3612.7 (9.5 to 16.5)9.5 (6.7 to 12.9)
Change from baseline at Week 4011.9 (8.8 to 15.6)11.1 (8.1 to 14.8)
Change from baseline at Week 4411.9 (8.8 to 15.6)9.2 (6.5 to 12.6)
Change from baseline at Week 4811.1 (8.1 to 14.7)11.9 (8.8 to 15.7)
Change from baseline at Week 5213.2 (10.0 to 17.1)11.4 (8.3 to 15.1)
Change from baseline at Week 5613.2 (10.0 to 17.1)11.7 (8.6 to 15.4)
Change from baseline at Week 6012.7 (9.5 to 16.5)11.7 (8.6 to 15.4)
Change from baseline at Week 6412.7 (9.5 to 16.5)12.5 (9.3 to 16.3)
Change from baseline at Week 6813.8 (10.4 to 17.7)12.2 (9.0 to 16.0)
Change from baseline at Week 7214.1 (10.7 to 18.0)13.6 (10.2 to 17.5)
Change from baseline at Week 7614.1 (10.7 to 18.0)13.6 (10.2 to 17.5)
Change from baseline at Week 8013.8 (10.4 to 17.7)15.2 (11.7 to 19.3)
Change from baseline at Week 8414.1 (10.7 to 18.0)14.6 (11.2 to 18.7)
Change from baseline at Week 8813.0 (9.7 to 16.8)14.4 (10.9 to 18.4)
Change from baseline at Week 9214.3 (10.9 to 18.3)16.0 (12.4 to 20.1)
Change from baseline at Week 9614.3 (10.9 to 18.3)14.6 (11.2 to 18.7)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.2 · 95% CI -3.5 to 3.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -4.4 to 3.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.0 · 95% CI -5.0 to 3.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.9 · 95% CI -1.9 to 6.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.7 · 95% CI -0.4 to 7.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.1 · 95% CI -1.3 to 7.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.6 · 95% CI -1.7 to 7.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -3.2 to 5.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.4 · 95% CI -0.7 to 8.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.0 · 95% CI -3.8 to 5.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.9 · 95% CI -1.4 to 7.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.7 · 95% CI -5.1 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.1 · 95% CI -2.5 to 6.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.8 · 95% CI -2.8 to 6.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -3.6 to 5.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.5 · 95% CI -4.0 to 5.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.8 · 95% CI -2.8 to 6.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.7 · 95% CI -4.3 to 5.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.7 · 95% CI -4.4 to 5.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.2 · 95% CI -6.0 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.4 · 95% CI -5.2 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.2 · 95% CI -5.7 to 3.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.5 · 95% CI -6.5 to 3.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.1 · 95% CI -5.1 to 4.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye

BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Baseline21.4 (17.3 to 25.9)17.9 (14.1 to 22.2)
Week 431.9 (27.2 to 36.9)34.7 (29.8 to 39.8)
Week 840.3 (35.2 to 45.5)41.2 (36.1 to 46.4)
Week 1243.5 (38.4 to 48.7)44.7 (39.6 to 49.9)
Week 1644.1 (38.9 to 49.3)42.5 (37.4 to 47.8)
Week 2044.1 (38.9 to 49.3)45.0 (39.8 to 50.2)
Week 2445.4 (40.3 to 50.6)47.4 (42.2 to 52.7)
Week 2848.6 (43.4 to 53.9)50.4 (45.2 to 55.6)
Week 3247.8 (42.6 to 53.1)49.6 (44.4 to 54.8)
Week 3647.6 (42.4 to 52.8)49.9 (44.6 to 55.1)
Week 4048.9 (43.7 to 54.1)49.3 (44.1 to 54.5)
Week 4450.3 (45.1 to 55.5)50.4 (45.2 to 55.6)
Week 4851.4 (46.1 to 56.6)49.6 (44.4 to 54.8)
Week 5249.7 (44.5 to 54.9)50.1 (44.9 to 55.4)
Week 5650.5 (45.3 to 55.7)50.9 (45.7 to 56.2)
Week 6048.9 (43.7 to 54.1)52.3 (47.1 to 57.5)
Week 6449.2 (44.0 to 54.4)50.7 (45.5 to 55.9)
Week 6848.9 (43.7 to 54.1)50.7 (45.5 to 55.9)
Week 7248.9 (43.7 to 54.1)49.3 (44.1 to 54.5)
Week 7648.9 (43.7 to 54.1)49.9 (44.6 to 55.1)
Week 8051.9 (46.7 to 57.1)50.1 (44.9 to 55.4)
Week 8448.4 (43.2 to 53.6)49.6 (44.4 to 54.8)
Week 8850.5 (45.3 to 55.7)50.7 (45.5 to 55.9)
Week 9250.5 (45.3 to 55.7)49.9 (44.6 to 55.1)
Week 9648.1 (42.9 to 53.3)49.1 (43.8 to 54.3)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.0 · 95% CI -9.2 to 1.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.1 · 95% CI -8.1 to 3.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.5 · 95% CI -8.4 to 3.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.3 · 95% CI -5.4 to 6.7Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.2 · 95% CI -8.2 to 4.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.1 · 95% CI -9.0 to 3.3Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.2 · 95% CI -9.3 to 2.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.1 · 95% CI -9.6 to 2.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.7 · 95% CI -9.6 to 2.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.7 · 95% CI -7.6 to 4.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -7.5 to 5.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.4 · 95% CI -5.4 to 6.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.8 · 95% CI -7.7 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.9 · 95% CI -7.7 to 4.0Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.7 · 95% CI -10.8 to 1.4Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.8 · 95% CI -8.9 to 3.2Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.1 · 95% CI -9.5 to 2.9Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.6 · 95% CI -7.9 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.0 · 95% CI -8.1 to 4.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.5 · 95% CI -5.6 to 6.6Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.4 · 95% CI -8.3 to 3.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.3 · 95% CI -7.4 to 4.5Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -6.5 to 5.8Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.0 · 95% CI -8.1 to 4.1Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryChange From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye

CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · micrometers
Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye
micrometersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 4-160.7 ± 126.55-149.2 ± 111.60
Change from baseline at Week 8-181.8 ± 142.11-159.6 ± 120.93
Change from baseline at Week 12-190.5 ± 148.05-167.6 ± 123.66
Change from baseline at Week 16-170.9 ± 152.48-137.7 ± 136.76
Change from baseline at Week 20-161.0 ± 151.81-165.3 ± 132.70
Change from baseline at Week 24-177.8 ± 150.62-137.3 ± 139.32
Change from baseline at Week 28-182.7 ± 156.04-166.6 ± 138.22
Change from baseline at Week 32-168.9 ± 157.61-142.6 ± 135.87
Change from baseline at Week 36-192.6 ± 156.51-170.2 ± 131.42
Change from baseline at Week 40-183.4 ± 156.83-146.5 ± 142.69
Change from baseline at Week 44-183.8 ± 161.42-172.7 ± 135.06
Change from baseline at Week 48-189.8 ± 158.35-147.8 ± 144.97
Change from baseline at Week 52-193.8 ± 157.22-173.9 ± 134.84
Change from baseline at Week 56-184.9 ± 162.66-149.9 ± 145.37
Change from baseline at Week 60-195.4 ± 161.34-172.2 ± 136.58
Change from baseline at Week 64-190.9 ± 160.06-153.1 ± 144.45
Change from baseline at Week 68-188.4 ± 161.63-172.9 ± 136.76
Change from baseline at Week 72-192.3 ± 160.70-153.1 ± 145.02
Change from baseline at Week 76-193.1 ± 162.00-173.1 ± 138.96
Change from baseline at Week 80-188.2 ± 165.90-155.6 ± 147.09
Change from baseline at Week 84-196.2 ± 161.97-173.4 ± 142.11
Change from baseline at Week 88-192.7 ± 162.46-158.3 ± 147.24
Change from baseline at Week 92-194.9 ± 162.35-173.9 ± 142.30
Change from baseline at Week 96-193.6 ± 163.97-159.3 ± 146.26
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -17.7 · 95% CI -32.6 to -2.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -29.5 · 95% CI -45.6 to -13.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -30.3 · 95% CI -46.9 to -13.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -40.2 · 95% CI -58.9 to -21.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.9 · 95% CI -20.9 to 15.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -47.8 · 95% CI -66.3 to -29.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -23.7 · 95% CI -42.0 to -5.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -33.7 · 95% CI -52.4 to -15.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -30.4 · 95% CI -48.0 to -12.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -44.7 · 95% CI -63.5 to -25.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -19.2 · 95% CI -37.3 to -1.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -49.9 · 95% CI -68.9 to -30.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -28.1 · 95% CI -45.8 to -10.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -43.1 · 95% CI -62.4 to -23.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -31.1 · 95% CI -49.5 to -12.8Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -45.8 · 95% CI -64.9 to -26.8Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -23.7 · 95% CI -42.0 to -5.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -47.3 · 95% CI -66.4 to -28.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -28.0 · 95% CI -46.5 to -9.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -40.9 · 95% CI -60.4 to -21.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -31.0 · 95% CI -49.6 to -12.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -42.6 · 95% CI -61.9 to -23.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -29.1 · 95% CI -47.9 to -10.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -42.6 · 95% CI -62.0 to -23.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye

CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 36, 40, 44, 48
Reported as:
Mean · micrometers
Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye
micrometersBrolucizumab 6 mgAflibercept 2 mg
Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye-187.4 ± 155.58-159.3 ± 135.92
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -36.1 · 95% CI -54.0 to -18.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye

CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 84, 88, 92, 96
Reported as:
Mean · micrometers
Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye
micrometersBrolucizumab 6 mgAflibercept 2 mg
Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye-194.3 ± 161.24-166.2 ± 142.81
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -36.3 · 95% CI -55.1 to -17.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryAverage Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye

CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · micrometers
Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye
micrometersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline over the period Week 4 to 48-178.7 ± 145.33-155.3 ± 126.83
Change from baseline over the period Week 4 to 96-185.4 ± 151.35-159.7 ± 131.74
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -30.8 · 95% CI -47.6 to -14.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -33.5 · 95% CI -50.8 to -16.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryChange From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye

CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 12, 48, 96
Reported as:
Mean · millimeters squared
Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye
millimeters squaredBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 12-2.2 ± 2.71-2.5 ± 4.02
Change from baseline at Week 48-2.3 ± 2.76-2.5 ± 4.04
Change from baseline at Week 96-2.5 ± 2.77-2.7 ± 4.03
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: 0.3 · 95% CI 0.0 to 0.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: 0.3 · 95% CI -0.1 to 0.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: 0.3 · 95% CI 0.0 to 0.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryChange From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye

CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Mean · micrometers
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
micrometersBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 4-51.7 ± 91.79-44.2 ± 80.37
Change from baseline at Week 8-55.0 ± 94.92-45.4 ± 84.99
Change from baseline at Week 12-52.7 ± 96.89-42.4 ± 85.48
Change from baseline at Week 16-50.5 ± 98.30-41.2 ± 84.78
Change from baseline at Week 20-49.2 ± 95.87-48.1 ± 88.08
Change from baseline at Week 24-53.4 ± 98.35-41.8 ± 90.17
Change from baseline at Week 28-56.4 ± 99.86-47.3 ± 87.90
Change from baseline at Week 32-49.8 ± 99.41-42.0 ± 90.50
Change from baseline at Week 36-59.1 ± 101.18-47.8 ± 89.64
Change from baseline at Week 40-55.9 ± 100.01-43.2 ± 91.94
Change from baseline at Week 44-56.2 ± 106.65-47.1 ± 90.03
Change from baseline at Week 48-54.8 ± 100.28-41.8 ± 93.99
Change from baseline at Week 52-58.4 ± 102.35-49.1 ± 90.31
Change from baseline at Week 56-57.3 ± 100.85-45.8 ± 91.95
Change from baseline at Week 60-60.3 ± 100.56-49.3 ± 90.52
Change from baseline at Week 64-58.0 ± 100.89-47.5 ± 92.59
Change from baseline at Week 68-56.7 ± 100.16-49.5 ± 91.20
Change from baseline at Week 72-58.6 ± 101.34-47.3 ± 92.25
Change from baseline at Week 76-59.7 ± 101.61-50.2 ± 91.51
Change from baseline at Week 80-57.8 ± 102.92-47.6 ± 92.34
Change from baseline at Week 84-60.4 ± 102.80-50.6 ± 92.57
Change from baseline at Week 88-59.7 ± 101.97-49.1 ± 94.52
Change from baseline at Week 92-60.1 ± 102.00-51.0 ± 91.79
Change from baseline at Week 96-58.9 ± 102.48-49.4 ± 94.86
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.1 · 95% CI -11.6 to 7.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.8 · 95% CI -13.6 to 6.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -4.5 · 95% CI -14.3 to 5.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.7 · 95% CI -13.7 to 6.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: 4.6 · 95% CI -5.5 to 14.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -5.8 · 95% CI -16.3 to 4.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.1 · 95% CI -13.1 to 7.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.0 · 95% CI -12.6 to 8.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -5.0 · 95% CI -15.2 to 5.1Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -6.6 · 95% CI -17.0 to 3.8Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.8 · 95% CI -13.4 to 7.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -7.0 · 95% CI -17.6 to 3.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.7 · 95% CI -12.9 to 7.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -5.0 · 95% CI -15.4 to 5.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -4.2 · 95% CI -14.3 to 5.9Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.9 · 95% CI -14.2 to 6.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -0.6 · 95% CI -10.7 to 9.6Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -4.6 · 95% CI -14.8 to 5.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.8 · 95% CI -13.1 to 7.4Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.7 · 95% CI -14.1 to 6.8Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.1 · 95% CI -13.5 to 7.3Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -4.0 · 95% CI -14.6 to 6.5Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -2.3 · 95% CI -12.6 to 8.0Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
  • Brolucizumab 6 mg vs Aflibercept 2 mg · ANOVA · Least squares mean difference: -3.0 · 95% CI -13.6 to 7.7Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
SecondaryPercentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye

Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

Time frame:
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 429.2 (24.6 to 34.1)36.9 (31.9 to 42.0)
Week 814.1 (10.7 to 18.0)22.8 (18.6 to 27.4)
Week 1213.5 (10.2 to 17.4)20.6 (16.6 to 25.1)
Week 1621.1 (17.0 to 25.6)35.5 (30.6 to 40.6)
Week 2025.1 (20.8 to 29.9)22.5 (18.3 to 27.1)
Week 2417.3 (13.6 to 21.5)36.9 (31.9 to 42.0)
Week 2815.9 (12.4 to 20.1)22.0 (17.8 to 26.5)
Week 3224.1 (19.8 to 28.7)34.4 (29.6 to 39.5)
Week 3613.5 (10.2 to 17.4)21.7 (17.6 to 26.2)
Week 4018.1 (14.3 to 22.4)33.9 (29.1 to 39.0)
Week 4423.8 (19.5 to 28.5)21.7 (17.6 to 26.2)
Week 4817.6 (13.8 to 21.8)33.9 (29.1 to 39.0)
Week 5219.7 (15.8 to 24.2)22.8 (18.6 to 27.4)
Week 5624.3 (20.0 to 29.0)33.6 (28.8 to 38.7)
Week 6020.0 (16.0 to 24.4)24.4 (20.1 to 29.1)
Week 6420.3 (16.3 to 24.7)35.5 (30.6 to 40.6)
Week 6823.2 (19.0 to 27.9)23.6 (19.3 to 28.2)
Week 7217.8 (14.1 to 22.1)34.7 (29.8 to 39.8)
Week 7621.6 (17.5 to 26.2)23.0 (18.8 to 27.7)
Week 8022.7 (18.5 to 27.3)33.9 (29.1 to 39.0)
Week 8418.9 (15.1 to 23.3)24.7 (20.3 to 29.4)
Week 8819.7 (15.8 to 24.2)31.7 (27.0 to 36.7)
Week 9217.3 (13.6 to 21.5)22.8 (18.6 to 27.4)
Week 9615.7 (12.1 to 19.8)30.4 (25.7 to 35.3)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.6 · 95% CI -13.2 to -0.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -8.5 · 95% CI -13.8 to -3.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.9 · 95% CI -12.2 to -1.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -14.2 · 95% CI -20.8 to -8.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.1 · 95% CI -2.9 to 9.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -19.2 · 95% CI -25.5 to -13.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.9 · 95% CI -11.6 to -0.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.8 · 95% CI -16.5 to -3.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -8.0 · 95% CI -13.6 to -2.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -15.4 · 95% CI -21.5 to -9.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.5 · 95% CI -3.2 to 8.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -15.9 · 95% CI -22.4 to -10.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.7 · 95% CI -8.5 to 3.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.0 · 95% CI -15.7 to -2.9Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.9 · 95% CI -9.8 to 2.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -15.1 · 95% CI -21.3 to -8.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.1 · 95% CI -6.1 to 6.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -16.6 · 95% CI -22.6 to -10.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.1 · 95% CI -7.0 to 5.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -11.0 · 95% CI -17.4 to -5.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.3 · 95% CI -11.3 to 0.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -12.0 · 95% CI -18.9 to -5.9Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.5 · 95% CI -11.4 to 0.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -14.5 · 95% CI -20.3 to -8.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye

Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

Time frame:
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 410.3 (7.4 to 13.8)8.4 (5.8 to 11.7)
Week 87.0 (4.6 to 10.1)8.7 (6.0 to 12.0)
Week 127.6 (5.1 to 10.8)8.7 (6.0 to 12.0)
Week 1612.7 (9.5 to 16.5)11.9 (8.8 to 15.7)
Week 2016.5 (12.9 to 20.7)7.9 (5.3 to 11.1)
Week 2410.5 (7.6 to 14.1)13.0 (9.7 to 16.9)
Week 289.2 (6.4 to 12.6)6.0 (3.8 to 8.9)
Week 3214.3 (10.9 to 18.3)14.1 (10.7 to 18.1)
Week 367.0 (4.6 to 10.1)8.4 (5.8 to 11.7)
Week 4013.2 (10.0 to 17.1)13.8 (10.5 to 17.8)
Week 4412.4 (9.2 to 16.2)8.1 (5.6 to 11.4)
Week 4811.1 (8.1 to 14.7)12.5 (9.3 to 16.3)
Week 529.2 (6.4 to 12.6)7.6 (5.1 to 10.8)
Week 5613.0 (9.7 to 16.8)13.6 (10.2 to 17.5)
Week 608.4 (5.8 to 11.7)8.4 (5.8 to 11.7)
Week 6410.3 (7.4 to 13.8)11.7 (8.6 to 15.4)
Week 6811.1 (8.1 to 14.7)8.1 (5.6 to 11.4)
Week 7211.1 (8.1 to 14.7)10.6 (7.6 to 14.2)
Week 769.2 (6.4 to 12.6)8.4 (5.8 to 11.7)
Week 8012.4 (9.2 to 16.2)12.2 (9.0 to 16.0)
Week 8410.5 (7.6 to 14.1)9.2 (6.5 to 12.6)
Week 8810.8 (7.8 to 14.4)10.6 (7.6 to 14.2)
Week 9210.8 (7.8 to 14.4)6.8 (4.4 to 9.8)
Week 9610.8 (7.8 to 14.4)10.3 (7.4 to 13.9)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.5 · 95% CI -2.5 to 5.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.1 · 95% CI -6.1 to 1.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -5.3 to 2.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.1 · 95% CI -4.5 to 4.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 8.2 · 95% CI 3.9 to 12.8Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.2 · 95% CI -7.9 to 1.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.8 · 95% CI -1.0 to 6.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.5 · 95% CI -5.5 to 4.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.8 · 95% CI -5.6 to 1.8Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.3 · 95% CI -6.0 to 3.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.8 · 95% CI -0.5 to 8.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.0 · 95% CI -6.2 to 2.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.2 · 95% CI -2.5 to 5.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.2 · 95% CI -5.9 to 3.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.6 · 95% CI -4.4 to 3.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.8 · 95% CI -6.2 to 2.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 2.6 · 95% CI -1.2 to 6.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.2 · 95% CI -4.2 to 4.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.4 · 95% CI -3.5 to 4.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.3 · 95% CI -4.8 to 4.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -3.3 to 5.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.1 · 95% CI -4.5 to 3.9Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.8 · 95% CI -0.1 to 8.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.2 · 95% CI -4.3 to 4.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye

Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.

Time frame:
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 418.1 (14.3 to 22.4)21.7 (17.6 to 26.2)
Week 816.2 (12.6 to 20.4)18.7 (14.9 to 23.1)
Week 1215.9 (12.4 to 20.1)17.6 (13.9 to 21.9)
Week 1615.9 (12.4 to 20.1)23.8 (19.6 to 28.5)
Week 2017.3 (13.6 to 21.5)16.0 (12.4 to 20.1)
Week 2410.5 (7.6 to 14.1)18.4 (14.6 to 22.8)
Week 2813.8 (10.4 to 17.7)15.7 (12.2 to 19.8)
Week 3218.1 (14.3 to 22.4)23.3 (19.1 to 28.0)
Week 3613.2 (10.0 to 17.1)18.7 (14.9 to 23.1)
Week 4015.4 (11.9 to 19.5)21.4 (17.3 to 26.0)
Week 4414.9 (11.4 to 18.9)14.4 (10.9 to 18.4)
Week 4813.0 (9.7 to 16.8)22.0 (17.8 to 26.5)
Week 5217.3 (13.6 to 21.5)19.0 (15.1 to 23.3)
Week 5619.7 (15.8 to 24.2)24.9 (20.6 to 29.7)
Week 6015.9 (12.4 to 20.1)21.7 (17.6 to 26.2)
Week 6419.2 (15.3 to 23.6)24.1 (19.8 to 28.8)
Week 6818.1 (14.3 to 22.4)23.3 (19.1 to 28.0)
Week 7217.0 (13.3 to 21.3)23.8 (19.6 to 28.5)
Week 7616.5 (12.9 to 20.7)22.0 (17.8 to 26.5)
Week 8021.1 (17.0 to 25.6)27.6 (23.1 to 32.5)
Week 8423.2 (19.0 to 27.9)24.7 (20.3 to 29.4)
Week 8821.9 (17.8 to 26.5)26.8 (22.4 to 31.7)
Week 9217.3 (13.6 to 21.5)23.0 (18.8 to 27.7)
Week 9616.5 (12.9 to 20.7)22.5 (18.3 to 27.1)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.5 · 95% CI -8.9 to 1.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.6 · 95% CI -7.6 to 2.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.6 · 95% CI -6.9 to 3.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -7.8 · 95% CI -13.0 to -2.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 1.3 · 95% CI -3.6 to 6.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -7.9 · 95% CI -12.6 to -3.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.1 · 95% CI -6.8 to 2.7Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.3 · 95% CI -10.5 to -0.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.5 · 95% CI -10.3 to -0.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.0 · 95% CI -11.2 to -0.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.5 · 95% CI -4.8 to 5.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.1 · 95% CI -13.8 to -3.9Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.8 · 95% CI -7.1 to 3.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.2 · 95% CI -11.1 to 0.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.6 · 95% CI -10.9 to -0.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.1 · 95% CI -10.9 to 0.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.2 · 95% CI -11.0 to -0.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.9 · 95% CI -12.5 to -1.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.5 · 95% CI -10.7 to -0.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.5 · 95% CI -12.4 to -0.9Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -1.4 · 95% CI -7.0 to 4.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.8 · 95% CI -10.5 to 1.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.6 · 95% CI -11.4 to 0.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.9 · 95% CI -11.5 to -0.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye

Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 435.9 (31.1 to 41.1)42.8 (37.7 to 48.0)
Week 820.3 (16.3 to 24.7)29.3 (24.7 to 34.2)
Week 1219.2 (15.3 to 23.6)27.6 (23.1 to 32.5)
Week 1629.7 (25.1 to 34.7)44.7 (39.6 to 49.9)
Week 2037.8 (32.9 to 43.0)29.8 (25.2 to 34.8)
Week 2425.7 (21.3 to 30.4)45.3 (40.1 to 50.5)
Week 2823.8 (19.5 to 28.5)27.4 (22.9 to 32.2)
Week 3234.6 (29.8 to 39.7)43.9 (38.8 to 49.1)
Week 3619.5 (15.5 to 23.9)28.5 (23.9 to 33.4)
Week 4028.4 (23.8 to 33.3)44.4 (39.3 to 49.7)
Week 4433.0 (28.2 to 38.0)29.3 (24.7 to 34.2)
Week 4825.9 (21.6 to 30.7)43.6 (38.5 to 48.9)
Week 5227.0 (22.6 to 31.9)29.5 (24.9 to 34.5)
Week 5634.3 (29.5 to 39.4)43.1 (38.0 to 48.3)
Week 6026.8 (22.3 to 31.6)32.0 (27.2 to 37.0)
Week 6428.4 (23.8 to 33.3)43.4 (38.2 to 48.6)
Week 6831.9 (27.2 to 36.9)30.6 (26.0 to 35.6)
Week 7227.0 (22.6 to 31.9)41.5 (36.4 to 46.7)
Week 7629.5 (24.9 to 34.4)29.8 (25.2 to 34.8)
Week 8032.7 (27.9 to 37.7)42.5 (37.4 to 47.8)
Week 8427.3 (22.8 to 32.1)31.4 (26.7 to 36.4)
Week 8828.4 (23.8 to 33.3)38.8 (33.8 to 43.9)
Week 9225.7 (21.3 to 30.4)28.2 (23.6 to 33.1)
Week 9624.6 (20.3 to 29.3)38.2 (33.2 to 43.4)
Statistical analysis
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -6.9 · 95% CI -14.2 to 0.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.2 · 95% CI -15.5 to -2.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -8.7 · 95% CI -15.0 to -2.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -15.7 · 95% CI -22.9 to -9.0Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 7.7 · 95% CI 0.9 to 14.8Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -20.0 · 95% CI -27.3 to -13.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.9 · 95% CI -10.4 to 2.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.7 · 95% CI -16.7 to -2.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.4 · 95% CI -15.8 to -3.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -16.5 · 95% CI -23.4 to -9.6Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 3.4 · 95% CI -3.3 to 10.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -18.1 · 95% CI -24.9 to -11.8Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -3.0 · 95% CI -9.2 to 3.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -9.4 · 95% CI -16.3 to -2.8Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -5.7 · 95% CI -12.5 to 1.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -15.5 · 95% CI -21.9 to -8.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: 0.9 · 95% CI -5.9 to 7.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -14.9 · 95% CI -21.4 to -8.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -0.8 · 95% CI -7.5 to 5.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -10.4 · 95% CI -17.2 to -3.4Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -4.5 · 95% CI -11.4 to 2.3Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -11.0 · 95% CI -18.2 to -4.1Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -2.9 · 95% CI -9.4 to 3.5Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
  • Brolucizumab 6 mg vs Aflibercept 2 mg · Regression, Logistic · Difference in proportions: -14.1 · 95% CI -21.3 to -7.2Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.
SecondaryPercentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye

A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.

Time frame:
Week 16
Reported as:
Number · percentage of subjects
Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye22.8 (18.6 to 27.5)32.1 (27.3 to 37.2)
SecondaryChange From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96

The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.

Time frame:
Baseline, Weeks 24, 48, 72, 96
Reported as:
Mean · score on a scale
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
score on a scaleBrolucizumab 6 mgAflibercept 2 mg
Change from baseline at Week 243.9 ± 10.093.5 ± 10.95
Change from baseline at Week 484.8 ± 11.573.6 ± 11.88
Change from baseline at Week 725.0 ± 13.383.2 ± 12.30
Change from baseline at Week 963.8 ± 14.062.6 ± 13.11
SecondaryPercentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)

Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point.

Time frame:
Week 48
Reported as:
Number · percentage of subjects
Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)
percentage of subjectsBrolucizumab 6 mg
Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)18.8
SecondaryPercentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye

Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 12, 48, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 126.96.6
Week 484.05.0
Week 962.12.7
SecondaryPercentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye

Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.

Time frame:
Baseline, Weeks 12, 48, 96
Reported as:
Number · percentage of subjects
Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
percentage of subjectsBrolucizumab 6 mgAflibercept 2 mg
Week 120.61.2
Week 480.60.3
Week 960.00.0

Adverse events

Collected over First treatment through study completion, an average of 96 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Brolucizumab 6mg4/370 (1.1%)79/370 (21.4%)176/370 (47.6%)
Aflibercept 2mg7/369 (1.9%)89/369 (24.1%)194/369 (52.6%)
Most frequent serious events
Showing 10 of 177
Most frequent serious events
EventBrolucizumab 6mgAflibercept 2mg
PneumoniaInfections and infestations2/3708/369
Cerebrovascular accidentNervous system disorders0/3704/369
DeathGeneral disorders0/3703/369
Uveitis - Study eyeEye disorders3/3700/369
Lower limb fractureInjury, poisoning and procedural complications3/3700/369
SyncopeNervous system disorders3/3702/369
ArrhythmiaCardiac disorders0/3702/369
Cardiac failureCardiac disorders2/3702/369
BronchitisInfections and infestations1/3702/369
FallInjury, poisoning and procedural complications0/3702/369
Most frequent other events
Showing 10 of 11
Most frequent other events
EventBrolucizumab 6mgAflibercept 2mg
Cataract - Study eyeEye disorders11/37043/369
NasopharyngitisInfections and infestations43/37031/369
Neovascular age-related macular degeneration - Fellow eyeEye disorders31/37032/369
Visual acuity reduced - Study eyeEye disorders31/37025/369
Back painMusculoskeletal and connective tissue disorders16/37028/369
HypertensionVascular disorders28/37025/369
InfluenzaInfections and infestations24/37027/369
Cataract - Fellow eyeEye disorders7/37022/369
BronchitisInfections and infestations22/37020/369
Conjunctival haemorrhage - Study eyeEye disorders17/37019/369

Baseline characteristics

This analysis population includes all randomized subjects who received at least 1 IVT injection of study treatment (Full Analysis Set).

Age, Continuous
Age, Continuous(years)Brolucizumab 6 mgAflibercept 2 mgTotal
Mean74.8 ± 8.5875.5 ± 7.8775.1 ± 8.24
Age, Customized
Age, Customized(participants)Brolucizumab 6 mgAflibercept 2 mgTotal
less than 50 years000
50-64 years442872
65-74 years124126250
75-84 years150167317
85 years and greater5248100
Sex: Female, Male
Sex: Female, Male(Participants)Brolucizumab 6 mgAflibercept 2 mgTotal
Female210212422
Male160157317
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Brolucizumab 6 mgAflibercept 2 mgTotal
Hispanic or Latino232548
Not Hispanic or Latino321322643
Unknown or Not Reported262248
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Brolucizumab 6 mgAflibercept 2 mgTotal
American Indian or Alaska Native000
Asian222345
Native Hawaiian or Other Pacific Islander000
Black or African American101
White340341681
More than one race213
Unknown or Not Reported549
Best Corrected Visual Acuity (BCVA) (letters read)
Best Corrected Visual Acuity (BCVA) (letters read)(letters)Brolucizumab 6 mgAflibercept 2 mgTotal
Mean61.5 ± 12.5960.8 ± 12.9361.2 ± 12.76
07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Singh RP, Jhaveri C, Wykoff CC, Gale RP, Staurenghi G, Iida T, Koh A, B G, Gedif K, Singer M. Efficacy Outcomes of Brolucizumab Versus Aflibercept in Neovascular Age-Related Macular Degeneration Patients with Early Residual Fluid. Ophthalmol Retina. 2022 May;6(5):377-386. doi: 10.1016/j.oret.2021.12.014. Epub 2021 Dec 27. PubMed 34968756 ↗
  • Mones J, Srivastava SK, Jaffe GJ, Tadayoni R, Albini TA, Kaiser PK, Holz FG, Korobelnik JF, Kim IK, Pruente C, Murray TG, Heier JS. Risk of Inflammation, Retinal Vasculitis, and Retinal Occlusion-Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER. Ophthalmology. 2021 Jul;128(7):1050-1059. doi: 10.1016/j.ophtha.2020.11.011. Epub 2020 Nov 15. PubMed 33207259 ↗
  • Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, Gomes AV, Warburton J, Weichselberger A, Holz FG; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020 Jan;127(1):72-84. doi: 10.1016/j.ophtha.2019.04.017. Epub 2019 Apr 12. PubMed 30986442 ↗

Study documents

  • Study protocol · Feb 10, 2017
  • Statistical analysis plan · May 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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Registry details

Key details

Study ID
NCT02434328
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
May 5, 2015
Start date
Jul 28, 2015
Primary completion
Apr 5, 2017
Completion
Mar 8, 2018
Results posted
Oct 31, 2019
Last update
Jan 16, 2025

Study contacts

Group Trial Lead
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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