A Phase 3 interventional study of Brolucizumab and Aflibercept in Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals. Completed at 116 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 39 studies in Macular Edema by Novartis — none open to participants now, none under way, none of them phase 3. Macular Edema · Novartis.
Among the 39 studies in Macular Edema by Novartis, this one has the largest enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2018, is one of 22 in phase 3, and was the 28th registered.
758 studies on the registry are indexed under Macular Edema; 66 are open to participants now.
Browse Macular Edema studies →None of the 39 studies in Macular Edema by Novartis is open now. The open studies under Macular Edema, anywhere →
Of the 44 Macular Edema studies recruiting now, 31 (70%) set no upper age limit and 7 (16%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 566 is above the median of 56 across 586 interventional studies indexed under Macular Edema.
Median enrollment 178 across the 36 interventional studies, 222 across the 3 observational. Of the 37 that completed or were terminated, 25 (68%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 39 studies in Macular Edema by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100.
Subjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase.
Disease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study.
To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-specified inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Drug: Brolucizumab
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Drug: Brolucizumab
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Drug: Aflibercept
Intravitreal injection
Also known as: RTH258, ESBA1008
Intravitreal injection
Also known as: Eylea
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Time frame: Baseline, Week 52
Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Time frame: Baseline and Week 40 through Week 52 (average)
Patients Maintained at q12w - Probability of Maintaining on q12w
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Time frame: Baseline (Week 0), Weeks 32, 36 and 48
Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 8 weeks (q8w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Time frame: Weeks 36 and 48
Change From Baseline in BCVA at Each Visit up to Week 52
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52
BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)
Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline, and Week 88 through Week 100 (average)
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
This outcome measure is pre-specified for brolucizumab treatment arms only
Time frame: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
This outcome measure is pre-specified for brolucizumab treatment arms only
Time frame: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline up to week 52
Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)
Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline, and Week 88 through Week 100 (average)
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit
Time frame: Baseline up to Week 52 and Week 100
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit
Time frame: Baseline, up to Week 52 and Week 100
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit
Time frame: Baseline, up to Week 52 and Week 100
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52
Assessed by angiography.
Time frame: Week 52
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100
Assessed by angiography.
Time frame: Week 100
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Time frame: Baseline, Weeks 28, 52, 76, 100
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Time frame: Baseline, Weeks 28, 52, 76, 100
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Time frame: Baseline, Weeks 28, 52, 76, 100
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Time frame: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)
Time frame: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
| Milestone | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Started | 190 | 189 | 187 |
| Completed | 157 | 154 | 153 |
| Not completed | 33 | 35 | 34 |
| Withdrew: Withdrawal by subject | 16 | 19 | 14 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
| Withdrew: Progressive disease | 0 | 1 | 0 |
| Withdrew: Physician decision | 3 | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 4 | 4 |
| Withdrew: Death | 4 | 8 | 7 |
| Withdrew: Adverse event | 6 | 3 | 7 |
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
| Scores on a scale | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 7.3 ± 0.66 | — | 10.6 ± 0.67 |
| LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | — | 9.2 ± 0.57 | 10.5 ± 0.57 |
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
| Scores on a scale | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 7.0 ± 0.63 | — | 10.5 ± 0.64 |
| LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | — | 9.0 ± 0.53 | 10.5 ± 0.53 |
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
| Probability | Brolucizumab 3 mg | Brolucizumab 6 mg |
|---|---|---|
| Prob. of maintaining on q12w - Week 0 | 1 (NA to NA) | 1 (NA to NA) |
| Prob. of maintaining on q12w - Week 32 | 0.758 (0.685 to 0.816) | 0.807 (0.739 to 0.860) |
| Prob. of maintaining on q12w - Week 36 | 0.545 (0.463 to 0.619) | 0.628 (0.548 to 0.698) |
| Prob. of maintaining on q12w - Week 48 | 0.474 (0.393 to 0.551) | 0.550 (0.468 to 0.625) |
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 8 weeks (q8w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
| Probability | Brolucizumab 3 mg | Brolucizumab 6 mg |
|---|---|---|
| Prob. of maintaining on q12w - Week 36 | 1 (NA to NA) | 1 (NA to NA) |
| Prob. of maintaining on q12w - Week 48 | 0.870 (0.772 to 0.928) | 0.876 (0.788 to 0.930) |
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
| Scores on a scale | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 4 (n=187, 186, 185) | 4.0 ± 5.02 | 4.5 ± 5.22 | 5.1 ± 6.74 |
| Week 6 (n=185,186,180) | 5.1 ± 5.86 | 6.0 ± 6.22 | 6.8 ± 6.80 |
| Week 8 (n=183,184,181) | 5.6 ± 5.90 | 6.6 ± 6.54 | 7.1 ± 7.57 |
| Week 12 (n=183,186,182) | 6.7 ± 5.93 | 7.3 ± 6.57 | 8.1 ± 7.63 |
| Week 16 (n=173,179,179) | 7.0 ± 7.00 | 7.5 ± 6.83 | 8.5 ± 7.36 |
| Week 18 (n=175,181,172) | 7.6 ± 6.35 | 8.0 ± 6.84 | 8.8 ± 7.27 |
| Week 20 (n=176,177,176) | 7.8 ± 7.59 | 8.3 ± 7.51 | 9.8 ± 7.47 |
| Week 24 (n=174,178,177) | 8.1 ± 6.42 | 9.3 ± 7.08 | 9.2 ± 7.84 |
| Week 28 (n=170,175,170) | 8.2 ± 6.58 | 9.6 ± 7.40 | 10.3 ± 7.26 |
| Week 32 (n=155,161,162) | 8.2 ± 7.76 | 9.2 ± 7.20 | 9.9 ± 7.89 |
| Week 36 (n=154,166,165) | 6.9 ± 8.10 | 8.6 ± 8.15 | 10.2 ± 7.84 |
| Week 40 (n=160,163,163) | 7.3 ± 10.47 | 9.5 ± 7.99 | 10.0 ± 8.28 |
| Week 44 (n=156,157,163) | 7.5 ± 10.92 | 9.6 ± 7.66 | 10.7 ± 8.25 |
| Week 48 (n=155,154,159) | 7.2 ± 11.53 | 10.0 ± 7.63 | 11.1 ± 8.75 |
| Week 52 (n=156,153,160) | 7.8 ± 10.72 | 10.2 ± 7.66 | 10.7 ± 8.87 |
Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
| BCVA letters read | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | 6.7 ± 0.77 | — | 10.6 ± 0.78 |
| LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | — | 8.6 ± 0.72 | 10.6 ± 0.73 |
This outcome measure is pre-specified for brolucizumab treatment arms only
| Probability | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Prob. of maintaining on q12w - Week 0 | 1 (NA to NA) | 1 (NA to NA) | — |
| Prob. of maintaining on q12w - Week 32 | 0.758 (0.685 to 0.816) | 0.807 (0.739 to 0.860) | — |
| Prob. of maintaining on q12w - Week 36 | 0.545 (0.463 to 0.619) | 0.628 (0.548 to 0.698) | — |
| Prob. of maintaining on q12w - Week 48 | 0.474 (0.393 to 0.551) | 0.550 (0.468 to 0.625) | — |
| Prob. of maintaining on q12w - Week 60 | 0.403 (0.323 to 0.482) | 0.520 (0.437 to 0.596) | — |
| Prob. of maintaining on q12w - Week 72 | 0.394 (0.314 to 0.473) | 0.487 (0.404 to 0.565) | — |
| Prob. of maintaining on q12w - Week 84 | 0.365 (0.285 to 0.445) | 0.460 (0.376 to 0.539) | — |
| Prob. of maintaining on q12w - Week 96 | 0.334 (0.254 to 0.415) | 0.441 (0.357 to 0.521) | — |
This outcome measure is pre-specified for brolucizumab treatment arms only
| Probability | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Prob. of maintaining on q12w - Week 0 | 1 (NA to NA) | 1 (NA to NA) | — |
| Prob. of maintaining on q12w - Week 32 | 1 (NA to NA) | 1 (NA to NA) | — |
| Prob. of maintaining on q12w - Week 36 | 1 (NA to NA) | 1 (NA to NA) | — |
| Prob. of maintaining on q12w - Week 48 | 0.870 (0.772 to 0.928) | 0.876 (0.788 to 0.930) | — |
| Prob. of maintaining on q12w - Week 60 | 0.740 (0.622 to 0.826) | 0.828 (0.730 to 0.892) | — |
| Prob. of maintaining on q12w - Week 72 | 0.723 (0.603 to 0.812) | 0.775 (0.670 to 0.851) | — |
| Prob. of maintaining on q12w - Week 84 | 0.670 (0.544 to 0.769) | 0.732 (0.621 to 0.816) | — |
| Prob. of maintaining on q12w - Week 96 | 0.613 (0.482 to 0.720) | 0.702 (0.587 to 0.791) | — |
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
| μm | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 4 (n=190, 0, 187) | -104.7 ± 6.11 | — | -104.1 ± 6.15 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 4 (n=0, 189, 187) | — | -105.6 ± 5.92 | -103.4 ± 5.95 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 6 (n=190, 0, 187) | -107.1 ± 6.24 | — | -119.3 ± 6.29 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 6 (n=0, 189, 187) | — | -116.1 ± 5.89 | -118.6 ± 5.92 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 8 (n=190, 0, 187) | -125.1 ± 6.06 | — | -126.1 ± 6.11 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg)- Week 8 (n=0, 189, 187) | — | -128.9 ± 5.82 | -125.6 ± 5.86 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 12 (n=190, 0, 187) | -131.0 ± 6.14 | — | -137.4 ± 6.19 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 12 (n=0, 189, 187) | — | -134.5 ± 6.22 | -137.3 ± 6.26 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 16 (n=190, 0, 187) | -142.3 ± 5.98 | — | -143.3 ± 6.02 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 16 (n=0, 189, 187) | — | -146.5 ± 5.83 | -143.1 ± 5.86 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 18 (n=190, 0, 187) | -138.1 ± 6.27 | — | -147.0 ± 6.32 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 18 (n=0, 189, 187) | — | -144.2 ± 5.96 | -146.8 ± 5.99 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 20 (n=190, 0, 187) | -151.8 ± 6.01 | — | -148.3 ± 6.06 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 20 (n=0, 189, 187) | — | -153.8 ± 5.71 | -148.0 ± 5.74 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 24 (n=190, 0, 187) | -152.6 ± 6.37 | — | -138.7 ± 6.42 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 24 (n=0, 189, 187) | — | -156.2 ± 6.30 | -138.4 ± 6.33 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 28 (n=190, 0, 187) | -163.4 ± 5.81 | — | -154.6 ± 5.85 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 28 (n=0, 189, 187) | — | -163.3 ± 5.97 | -154.6 ± 6.00 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 32 (n=190, 0, 187) | -147.4 ± 6.68 | — | -144.3 ± 6.73 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 32 (n=0, 189, 187) | — | -156.0 ± 6.35 | -144.2 ± 6.38 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 36 (n=190, 0, 187) | -119.8 ± 7.74 | — | -156.0 ± 7.81 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 36 (n=0, 189, 187) | — | -135.1 ± 7.01 | -155.5 ± 7.05 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 40 (n=190, 0, 187) | -155.8 ± 6.46 | — | -149.7 ± 6.51 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 40 (n=0, 189, 187) | — | -156.9 ± 6.68 | -150.4 ± 6.72 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 44 (n=190, 0, 187) | -155.4 ± 6.56 | — | -163.4 ± 6.62 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 44 (n=0, 189, 187) | — | -162.2 ± 6.17 | -163.3 ± 6.21 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 48 (n=190, 0, 187) | -144.2 ± 6.92 | — | -157.8 ± 6.98 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 48 (n=0, 189, 187) | — | -153.5 ± 6.52 | -158.2 ± 6.55 |
| LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 52 (n=190, 0, 187) | -156.4 ± 6.70 | — | -160.7 ± 6.75 |
| LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 52 (n=0, 189, 187) | — | -165.5 ± 6.17 | -160.4 ± 6.21 |
Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
| micrometers | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | -167.1 ± 6.54 | — | -168.8 ± 6.59 |
| LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | — | -171.9 ± 6.18 | -168.5 ± 6.22 |
Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 4 | 26 | 23 | 27 |
| Week 6 | 20 | 17 | 17 |
| Week 8 | 10 | 9 | 12 |
| Week 12 | 11 | 8 | 8 |
| Week16 | 6 | 6 | 7 |
| Week18 | 7 | 4 | 6 |
| Week 20 | 5 | 4 | 6 |
| Week 24 | 7 | 3 | 6 |
| Week 28 | 5 | 2 | 3 |
| Week 32 | 11 | 1 | 6 |
| Week 36 | 16 | 14 | 4 |
| Week 40 | 8 | 5 | 6 |
| Week 44 | 4 | 4 | 4 |
| Week 48 | 7 | 8 | 3 |
| Week 52 | 4 | 4 | 4 |
| Week 56 | 9 | 3 | 5 |
| Week 60 | 9 | 5 | 5 |
| Week 64 | 6 | 4 | 5 |
| Week 68 | 6 | 4 | 3 |
| Week 72 | 5 | 4 | 4 |
| Week 76 | 4 | 4 | 4 |
| Week 80 | 5 | 4 | 5 |
| Week 84 | 6 | 3 | 3 |
| Week 88 | 7 | 2 | 4 |
| Week 92 | 4 | 2 | 4 |
| Week 96 | 5 | 3 | 5 |
| Week 100 | 3 | 2 | 2 |
Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 4 | 176 | 169 | 169 |
| Week 6 | 177 | 169 | 169 |
| Week 8 | 166 | 161 | 164 |
| Week 12 | 167 | 162 | 165 |
| Week 16 | 155 | 150 | 156 |
| Week 18 | 152 | 149 | 154 |
| Week 20 | 142 | 147 | 145 |
| Week 24 | 142 | 140 | 153 |
| Week 28 | 139 | 130 | 144 |
| Week 32 | 143 | 131 | 156 |
| Week 36 | 153 | 141 | 144 |
| Week 40 | 129 | 114 | 150 |
| Week 44 | 127 | 118 | 135 |
| Week 48 | 132 | 123 | 147 |
| Week 52 | 113 | 114 | 137 |
| Week 56 | 111 | 103 | 138 |
| Week 60 | 119 | 115 | 126 |
| Week 64 | 102 | 105 | 131 |
| Week 68 | 109 | 98 | 118 |
| Week 72 | 107 | 103 | 126 |
| Week 76 | 98 | 96 | 118 |
| Week 80 | 96 | 85 | 120 |
| Week 84 | 102 | 92 | 108 |
| Week 88 | 89 | 85 | 114 |
| Week 92 | 91 | 86 | 105 |
| Week 96 | 92 | 90 | 107 |
| Week 100 | 87 | 79 | 101 |
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 4 | 177 | 172 | 171 |
| Week 6 | 177 | 173 | 169 |
| Week 8 | 166 | 162 | 164 |
| Week 12 | 168 | 162 | 165 |
| Week 16 | 156 | 150 | 156 |
| Week 18 | 153 | 149 | 154 |
| Week 20 | 142 | 147 | 145 |
| Week 24 | 142 | 140 | 153 |
| Week 28 | 139 | 130 | 144 |
| Week 32 | 143 | 131 | 156 |
| Week 36 | 153 | 141 | 144 |
| Week 40 | 129 | 114 | 150 |
| Week 44 | 127 | 118 | 135 |
| Week 48 | 132 | 123 | 147 |
| Week 52 | 113 | 114 | 137 |
| Week 56 | 111 | 103 | 138 |
| Week 60 | 120 | 115 | 126 |
| Week 64 | 102 | 105 | 131 |
| Week 68 | 109 | 98 | 118 |
| Week 72 | 107 | 103 | 126 |
| Week 76 | 98 | 96 | 118 |
| Week 80 | 96 | 85 | 120 |
| Week 84 | 102 | 92 | 108 |
| Week 88 | 89 | 85 | 114 |
| Week 92 | 91 | 86 | 105 |
| Week 96 | 92 | 90 | 107 |
| Week 100 | 87 | 79 | 101 |
Assessed by angiography.
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | 114 | 108 | 140 |
Assessed by angiography.
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | 94 | 80 | 104 |
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 44 | 49 | 39 |
| Week 52 | 53 | 55 | 40 |
| Week 76 | 59 | 55 | 51 |
| Week 100 | 60 | 61 | 54 |
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
| Percentage estimates | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185,0, 184) | 23.3 | — | 21.7 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 28 (n = 0, 186, 184) | — | 25.8 | 21.7 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 185,0, 184) | 28.0 | — | 22.3 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | — | 29.0 | 22.2 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185,0, 184) | 31.2 | — | 28.4 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 76 (n = 0, 186, 184) | — | 29.0 | 28.3 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185,0, 184) | 31.7 | — | 30.1 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 100 (n = 0, 186, 184) | — | 32.1 | 30.0 |
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 23 | 32 | 22 |
| Week 52 | 24 | 39 | 30 |
| Week 76 | 27 | 40 | 42 |
| Week 100 | 29 | 44 | 41 |
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
| Percentage estimates | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185, 0, 184) | 12.1 | — | 12.3 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 0, 186, 184) | — | 16.8 | 12.2 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E.(%) at Week 52 (n = 185, 0, 184) | 12.6 | — | 16.8 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | — | 20.5 | 16.7 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185, 0, 184) | 14.2 | — | 23.4 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 0, 186, 184) | — | 21.1 | 23.3 |
| Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185, 0, 184) | 15.2 | — | 22.9 |
| Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 0, 186, 184) | — | 23.2 | 22.8 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 5.5 ± 11.89 | 6.0 ± 14.27 | 7.8 ± 12.68 |
| Week 52 (n = 151,148,157) | 4.6 ± 12.89 | 6.7 ± 13.24 | 8.5 ± 12.99 |
| Week 76 (n = 133,138,143) | 6.7 ± 13.21 | 5.8 ± 14.50 | 7.1 ± 12.49 |
| Week 100 (n=140,141,142) | 6.6 ± 15.16 | 6.5 ± 14.41 | 6.2 ± 13.16 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 7.8 ± 14.75 | 10.8 ± 18.11 | 11.3 ± 15.88 |
| Week 52 (n = 151,148,157) | 6.6 ± 14.74 | 11.2 ± 17.18 | 10.7 ± 17.62 |
| Week 76 (n = 133,138,143) | 7.5 ± 14.89 | 10.0 ± 17.80 | 11.7 ± 17.97 |
| Week 100 (n=140,141,142) | 10.4 ± 17.87 | 13.5 ± 17.97 | 11.5 ± 16.21 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 2.2 ± 21.02 | 2.4 ± 21.92 | 4.3 ± 23.61 |
| Week 52 (n = 151,148,157) | 1.0 ± 19.55 | 4.9 ± 19.54 | 5.3 ± 22.16 |
| Week 76 (n = 133,138,143) | 4.1 ± 19.75 | 2.1 ± 22.78 | 3.9 ± 21.72 |
| Week 100 (n=140,141,142) | 3.1 ± 19.90 | 3.1 ± 18.37 | 2.0 ± 19.73 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 8.4 ± 19.83 | 13.2 ± 24.93 | 13.7 ± 20.51 |
| Week 52 (n = 151,148,157) | 8.1 ± 21.41 | 14.1 ± 24.17 | 13.4 ± 23.64 |
| Week 76 (n = 133,138,143) | 11.7 ± 20.00 | 14.9 ± 23.35 | 12.4 ± 20.92 |
| Week 100 (n=140,141,142) | 11.6 ± 22.23 | 15.7 ± 22.01 | 10.4 ± 23.50 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 6.0 ± 18.39 | 7.9 ± 21.58 | 9.0 ± 19.35 |
| Week 52 (n = 151,148,157) | 4.2 ± 22.20 | 9.0 ± 19.42 | 9.9 ± 20.05 |
| Week 76 (n = 133,138,143) | 8.3 ± 20.45 | 8.1 ± 19.20 | 7.0 ± 18.39 |
| Week 100 (n=140,141,142) | 6.4 ± 20.68 | 7.0 ± 19.24 | 6.7 ± 19.15 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 2.7 ± 17.79 | 2.2 ± 18.00 | 3.9 ± 14.15 |
| Week 52 (n = 151,148,157) | 3.1 ± 18.82 | 2.7 ± 17.53 | 3.8 ± 15.98 |
| Week 76 (n = 133,138,143) | 3.6 ± 17.24 | 0.5 ± 18.95 | 1.7 ± 16.49 |
| Week 100 (n=140,141,142) | 2.5 ± 19.68 | 2.0 ± 21.82 | 1.4 ± 16.38 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 7.8 ± 20.63 | 8.2 ± 22.21 | 8.7 ± 19.71 |
| Week 52 (n = 151,148,157) | 7.9 ± 22.93 | 9.6 ± 21.42 | 11.3 ± 21.34 |
| Week 76 (n = 133,138,143) | 10.3 ± 21.07 | 11.5 ± 21.10 | 11.2 ± 20.93 |
| Week 100 (n=140,141,142) | 11.7 ± 25.28 | 9.4 ± 23.62 | 10.9 ± 22.22 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 8.0 ± 24.93 | 6.5 ± 26.81 | 9.4 ± 27.34 |
| Week 52 (n = 151,148,157) | 6.9 ± 23.88 | 6.1 ± 29.11 | 11.3 ± 25.47 |
| Week 76 (n = 133,138,143) | 9.9 ± 25.10 | 6.8 ± 29.48 | 7.4 ± 27.76 |
| Week 100 (n=140,141,142) | 9.3 ± 28.27 | 9.6 ± 28.88 | 6.9 ± 26.19 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 6.3 ± 21.80 | 6.1 ± 25.16 | 7.1 ± 22.06 |
| Week 52 (n = 151,148,157) | 3.8 ± 23.05 | 4.1 ± 25.36 | 9.0 ± 22.68 |
| Week 76 (n = 133,138,143) | 5.2 ± 22.93 | 4.2 ± 25.56 | 6.8 ± 22.59 |
| Week 100 (n=140,141,142) | 5.5 ± 24.89 | 3.2 ± 25.79 | 5.6 ± 25.35 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 4.7 ± 16.40 | 1.9 ± 17.74 | 6.7 ± 15.06 |
| Week 52 (n = 97,98,91) | 5.2 ± 16.51 | 3.6 ± 18.73 | 6.4 ± 17.64 |
| Week 76 (n = 86,86,83) | 5.5 ± 16.09 | 2.9 ± 18.34 | 6.5 ± 19.13 |
| Week 100 (n=86,86,81) | 6.2 ± 16.58 | 4.3 ± 20.24 | 2.3 ± 18.84 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 2.6 ± 14.37 | 2.6 ± 18.20 | 1.8 ± 14.49 |
| Week 52 (n = 148,147,152) | 2.0 ± 16.11 | 2.0 ± 12.59 | 1.6 ± 15.13 |
| Week 76 (n = 131,137,140) | 1.7 ± 13.58 | 0.2 ± 17.01 | 0.2 ± 13.90 |
| Week 100 (n=139,138,138) | 2.0 ± 14.14 | 1.3 ± 15.79 | 0.5 ± 16.94 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 3.6 ± 20.89 | 1.6 ± 22.05 | 9.2 ± 22.82 |
| Week 52 (n = 151,148,156) | 1.3 ± 22.51 | 4.1 ± 22.97 | 8.5 ± 22.98 |
| Week 76 (n = 133, 138, 143) | 5.6 ± 21.01 | 1.1 ± 24.33 | 7.3 ± 20.94 |
| Week 100 (n=140, 140, 142) | 3.4 ± 21.87 | -0.4 ± 24.36 | 6.3 ± 24.81 |
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
| overall scores | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Week 28 | 0.9 ± 19.50 | 3.0 ± 22.10 | 6.1 ± 19.25 |
| Week 52 (n = 151,148,157) | 4.3 ± 22.50 | 6.8 ± 22.32 | 6.8 ± 24.94 |
| Week 76 (n = 133, 138, 143) | 2.3 ± 23.53 | 6.3 ± 24.18 | 8.2 ± 20.93 |
| Week 100 (n=140, 141, 142) | 2.3 ± 23.97 | 6.9 ± 23.55 | 8.8 ± 21.72 |
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Number of subjects with at least one AE | 103 | 92 | 94 |
| Cataract | 17 | 16 | 13 |
| Conjunctival haemorrhage | 19 | 16 | 19 |
| Intraocular pressure increased | 14 | 11 | 3 |
| Vitreous detachment | 9 | 10 | 3 |
| Vitreous floaters | 7 | 10 | 6 |
| Diabetic retinal oedema | 12 | 9 | 4 |
| Conjunctivitis | 4 | 6 | 1 |
| Dry eye | 10 | 6 | 5 |
| Eye pain | 3 | 6 | 5 |
| Posterior capsule opacification | 3 | 6 | 3 |
| Eye irritation | 3 | 5 | 4 |
| Blepharitis | 3 | 4 | 4 |
| Keratitis | 0 | 4 | 3 |
| Vitreous haemorrhage | 2 | 4 | 3 |
| Punctate keratitis | 8 | 3 | 1 |
| Vision blurred | 6 | 3 | 1 |
| Visual acuity reduced | 7 | 3 | 9 |
| Iridocyclitis | 4 | 2 | 0 |
| Ocular hypertension | 4 | 2 | 2 |
| Uveitis | 4 | 2 | 0 |
| Corneal abrasion | 3 | 1 | 4 |
| Retinal exudates | 7 | 1 | 3 |
| Cataract subcapsular | 1 | 0 | 4 |
| Conjunctival hyperaemia | 4 | 0 | 1 |
| Vitreoretinal traction syndrome | 1 | 0 | 5 |
| Participants | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|---|
| Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | 146 | 146 | 143 |
Collected over Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brolucizumab 3mg | 4/190 (2.1%) | 58/190 (30.5%) | 146/190 (76.8%) |
| Brolucizumab 6mg | 8/189 (4.2%) | 59/189 (31.2%) | 148/189 (78.3%) |
| Aflibercept 2mg | 7/187 (3.7%) | 63/187 (33.7%) | 137/187 (73.3%) |
| Overall | 19/566 (3.4%) | 180/566 (31.8%) | 431/566 (76.1%) |
| Event | Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | Overall |
|---|---|---|---|---|
| Cardiac failure congestiveCardiac disorders | 5/190 | 2/189 | 5/187 | 12/566 |
| Cataract - Study eyeEye disorders | 1/190 | 5/189 | 3/187 | 9/566 |
| Cataract - Fellow eyeEye disorders | 0/190 | 3/189 | 4/187 | 7/566 |
| Cerebrovascular accidentNervous system disorders | 3/190 | 4/189 | 4/187 | 11/566 |
| Renal failureRenal and urinary disorders | 1/190 | 1/189 | 4/187 | 6/566 |
| Coronary artery diseaseCardiac disorders | 1/190 | 2/189 | 3/187 | 6/566 |
| Myocardial infarctionCardiac disorders | 2/190 | 3/189 | 3/187 | 8/566 |
| OsteomyelitisInfections and infestations | 1/190 | 2/189 | 3/187 | 6/566 |
| COVID-19Infections and infestations | 2/190 | 3/189 | 2/187 | 7/566 |
| Diabetes mellitusMetabolism and nutrition disorders | 0/190 | 3/189 | 0/187 | 3/566 |
| Event | Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | Overall |
|---|---|---|---|---|
| HypertensionVascular disorders | 22/190 | 21/189 | 24/187 | 67/566 |
| Urinary tract infectionInfections and infestations | 17/190 | 20/189 | 8/187 | 45/566 |
| NasopharyngitisInfections and infestations | 20/190 | 18/189 | 16/187 | 54/566 |
| Conjunctival haemorrhage - Study eyeEye disorders | 19/190 | 16/189 | 19/187 | 54/566 |
| Cataract - Study eyeEye disorders | 17/190 | 12/189 | 10/187 | 39/566 |
| Diabetic retinal oedema - Fellow eyeEye disorders | 17/190 | 12/189 | 12/187 | 41/566 |
| Intraocular pressure increased - Study eyeInvestigations | 14/190 | 11/189 | 3/187 | 28/566 |
| Cataract - Fellow eyeEye disorders | 11/190 | 12/189 | 5/187 | 28/566 |
| Diabetic retinal oedema - Study eyeEye disorders | 12/190 | 9/189 | 4/187 | 25/566 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/190 | 6/189 | 5/187 | 23/566 |
| Age, Categorical(Participants) | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 97 | 104 | 93 | 294 |
| >=65 years | 93 | 85 | 94 | 272 |
| Age, Continuous(years) | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|
| Mean | 64.4 ± 9.76 | 62.4 ± 10.14 | 63.9 ± 10.09 | 63.6 ± 10.01 |
| Sex: Female, Male(Participants) | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|
| Female | 71 | 79 | 61 | 211 |
| Male | 119 | 110 | 126 | 355 |
| Race (NIH/OMB)(Participants) | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 25 | 25 | 26 | 76 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 2 |
| Black or African American | 13 | 4 | 7 | 24 |
| White | 151 | 158 | 152 | 461 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Showing the first 100 of 116 sites across 14 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Ran from Jul 2018 to primary completion in Nov 2020, 27 months.
Results were first posted in Oct 2022, 1 year 11 months after primary completion. A results delay was requested in Jan 2021.
Of 52 industry-sponsored phase 3 interventional studies under Macular Edema, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 33. This study's 27 months is above that.
Counting every sponsor, half of 65 studies reached it within 25 months; a quarter within 18 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brolucizumab