A Phase 3 interventional study of Brolucizumab and Aflibercept in Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals. Completed at 78 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
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 is the 9th largest by 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 29th 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 360 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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This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).
The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked 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, there was a post-treatment follow-up period from Week 96 to Week 100 and an exit visit at Week 100. Subjects were assigned to one of two treatment arms in a 1:1 ratio: brolucizumab 6 mg/0.05 mL (5 loading doses each administered every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase with an option to extend treatment interval by 4 weeks during the second year) or aflibercept 2 mg/0.05 mL (5 loading doses each administered every 4 weeks (q4w) during loading phase then q8w during maintenance phase).
Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Week 32 and Week 36, i.e., 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab, and at Week 48, Week 60 and Week 72 (i.e., every 12 weeks). In the brolucizumab arm, subjects who qualified for q12w during this 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 Week 72.
A one-time disease stability assessment was performed by the masked investigator at Week 72 in both treatment arms with the purpose of evaluating the potential for treatment interval extension by 4 weeks. The subjects in the brolucizumab arm who demonstrated disease stability in the one-time assessment at Week 72 under their current assigned treatment regimen (q12w or q8w) were considered for treatment interval extension. To evaluate the adequacy of the individualized q8w, q12w or q16w treatment intervals in the brolucizumab arm, DAAs were performed at every visit from Week 72 up to and including Week 96 (i.e., every 4 weeks) and subjects had their treatment interval modified accordingly. If after Week 72 disease activity had been identified by the masked investigator at a scheduled treatment visit (according to the subject specific treatment schedule q12w or q16w) the subject was assigned to q8w treatment schedule.
Key Inclusion Criteria:
General
Study Eye
Visual impairment due to DME with:
DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of >= 320 micrometers (μm) on SD-OCT at screening If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements.
Key Exclusion Criteria:
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 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
Drug: Brolucizumab
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Drug: Aflibercept
Intravitreal injection
Also known as: RTH258, ESBA1008
Intravitreal injection
Also known as: Eylea
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 52
Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 40 through Week 52. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, period Week 40 through Week 52
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100.
The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
Time frame: Week 52, Week 100
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36
The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
Time frame: Week 36, Week 52
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w/q16w up to Week 100, Within Those Patients That Qualified for q12w at Week 36
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
Time frame: Week 36, Week 100
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained on q16w up to Week 100 Within the Patients on q12w at Week 68 and on q16w at Week 76
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
Time frame: Week 68, Week 76, Week 100
(Brolucizumab Treatment Arm Only): Percentage of Participants Re-assigned and Maintained on q12w up to Week 100 Within the Patients on q8w at Week 68 and on q12w at Week 80
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
Time frame: Week 68, Week 80, Week 100
(Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks)
Reported categorically for the subjects who completed the study treatment period: every 8 weeks (q8w), Every 12 weeks (q12w), Every 16 weeks (q16w)
Time frame: Week 100
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 4 through Week 52, Week 4 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, period Week 4 through Week 52, period Week 4 through Week 100
Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 20 to Week 52/100 and Week 28 to Week 52/100 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 20 through Week 52, Week 20 through Week 100, Week 28 through Week 52, Week 28 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, period Week 20 through Week 52, period Week 20 through Week 100, period Week 28 through Week 52, period Week 28 through Week 100
Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 88 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, period Week 88 through Week 100
Percentage of Participants Who Gained >= 5 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants Who Gained >= 10 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants Who Gained >= 15 Letters in BCVA From Baseline or Reached BCVA >= 84 Letters at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants Who Lost >= 5 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants Who Lost >= 10 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants Who Lost >= 15 ETDRS Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants With an Absolute Best Corrected Visual Acuity (BCVA) >= 73 ETDRS Letters at Each Post-baseline Visit for the Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Mean Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit for the Study Eye
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Average Mean Change From Baseline in Central Subfield Thickness (CSFT) Over the Period Week 40 Through Week 52 / Week 88 Through Week 100 for the Study Eye
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. For each participants, this endpoint was derived as the average of the changes from Baseline to Weeks 40, 44, 48, 52. Then the same was derived over the period Week 88 through Week 100, considering the average of the changes from Baseline to Weeks 88, 92, 96, 100. This endpoint was only assessed in the year-2 analysis (Week 100).
Time frame: Baseline, period Week 40 through Week 52, period Week 88 through Week 100
Average Mean Change From Baseline in CSFT Over the Period Week 4 to Week 52 / 100 for the Study Eye
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, period Week 4 through Week 52, period Week 4 through Week 100
Percentage of Participants With Normal CSFT Thickness (<280 Micrometers) at Each Post-baseline Visit for the Study Eye
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Patients With Presence of Subretinal Fluid (SRF) in the Study Eye at Each Post-baseline Visit
Presence of Subretinal Fluid (SRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Subretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Patients With Presence of Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit
Presence of Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Intraretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Patients With Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the Study Eye at Each Post-baseline Visit
Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Fluid status (SRF and/or IRF) assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 18, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72, Week 76, Week 80, Week 84, Week 88, Week 92, Week 96, Week 100
Percentage of Participants With Presence of Leakage on Fluorescein Angiography (FA) at Weeks 52 and 100
Presence of leakage on Fluorescein Angiography as assessed by fluorescein angiography. Leakage on FA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Week 52, Week 100
Percentage of Participants With With >=2-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Percentage of Participants With With >=3-step Improvement From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Percentage of Participants With With >=2-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Percentage of Participants With With >=3-step Worsening From Baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) Score
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Week 100
Number of Participants With Ocular and Non-ocular Adverse Events (AEs)
The number of participants with ocular and non-ocular adverse events was was assessed by CTCAE and reported categorically: Mild, Moderate, Severe.
Time frame: From randomization till 30 days safety follow-up, assessed up to 35 months.
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Composite Score
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - General Vision
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Ocular Pain
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Near Activities
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Distance Activities
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Social Functioning
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Mental Health
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Role Difficulties
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Dependency
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Driving
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Color Vision
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): Subscale Score - Peripheral Vision
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25): General Health Rating
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
Time frame: Baseline, Week 28, Week 52, Week 76, Week 100
Systemic Brolucizumab Concentration
Serum samples were taken approximately 24 hours after the first dose and 24 hours after the treatment at Week 24 to confirm the systemic brolucizumab exposure in patients with visual impairment due to diabetic macular edema.
Time frame: Up to Week 24
Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm
Integrated ADA Status was categorized: ADA negative or ADA positive with no boost, Induced or Boosted, Missing ADA at pre-dose or no post-dose ADA data. * ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points. * ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point. * Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point. * Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
Time frame: Up to Week 100
Distribution of Integrated Anti-Drug Antibody (ADA) Status in the Brolucizumab Arm - Adjusted for Pre-existing ADA Status
Integrated ADA Status - adjusted for pre-existing ADA status was categorized: ADA negative, ADA positive with no boost, Induced, Boosted. * ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points. * ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point. * Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point. * Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
Time frame: Up to Week 100
Pre-existing ADA Status and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye
Pre-existing ADA status and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: Negative, Positive.
Time frame: Up to Week 100
Integrated ADA Status up to Week 100 and Incidence of Adverse Event of Special Interest (AESI) in the Study Eye.
Integrated ADA status up to Week 100 and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: ADA-negative or no boost, Induced or boosted.
Time frame: Up to Week 100
This study was conducted in 79 centers in 23 countries: Belgium (1), Bulgaria (3), Czech Republic (3), Denmark (2), Estonia (2), France (12), Germany (7), Hungary (5), India (5), Republic of Korea (6), Latvia (1), Lebanon (3), Lithuania (2), Malaysia (2), Norway (1), Poland (1), Russia (5), Singapore (2), Slovakia (5), Sweden (1), Switzerland (2), Taiwan (3), Turkey (5).
| Milestone | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Started | 179 | 181 |
| Completed | 143 | 156 |
| Not completed | 36 | 25 |
| Withdrew: Adverse event | 5 | 4 |
| Withdrew: Death | 13 | 9 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Physician decision | 2 | 3 |
| Withdrew: Withdrawal by subject | 14 | 7 |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye | 10.6 (9.3 to 11.9) | 9.4 (8.1 to 10.7) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 40 through Week 52. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study Eye | 10.3 (9.1 to 11.5) | 9.4 (8.2 to 10.6) |
The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
| Percentage of participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 48 | 50.3 (42.5 to 57.7) | — |
| Week 96 | 36.8 (29.1 to 45.5) | — |
The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
| Percentage of participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36 | 95.1 (87.4 to 98.1) | — |
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
| Percentage of participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w/q16w up to Week 100, Within Those Patients That Qualified for q12w at Week 36 | 69.6 (57.4 to 78.9) | — |
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
| Percentage of participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| (Brolucizumab Treatment Arm Only): Percentage of Participants Maintained on q16w up to Week 100 Within the Patients on q12w at Week 68 and on q16w at Week 76 | 87.9 (73.3 to 94.8) | — |
Disease activity assessments (DAAs) were performed to identify q8w-need at pre-specified visits (Weeks 32, 36, 48, 60, 72 and every visit from Week 72 through Week 96). Weeks 32 and 36 were the two DAA visits of the initial q12w cycle after the loading phase of the brolucizumab arm. At Week 72 or Week 76 (if DAA/disease stability assessment was missed at Week 72), participants in the brolucizumab were evaluated for an additional 4-week dose regimen extension. The number of participants maintaining every 12 weeks (q12w) treatment status in the Brolucizumab arm was derived based on Kaplan-Meier estimates time-to-first q8w treatment need. Positive treatment status was defined as intravitreal treatment (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\].
| Percentage of participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| (Brolucizumab Treatment Arm Only): Percentage of Participants Re-assigned and Maintained on q12w up to Week 100 Within the Patients on q8w at Week 68 and on q12w at Week 80 | 73.1 (54.5 to 85.0) | — |
Reported categorically for the subjects who completed the study treatment period: every 8 weeks (q8w), Every 12 weeks (q12w), Every 16 weeks (q16w)
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| q8w | 74 | — |
| q12w | 32 | — |
| q16w | 35 | — |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 5.1 (4.3 to 6.0) | 4.2 (3.4 to 5.1) |
| Week 6 | 6.8 (5.9 to 7.6) | 5.9 (5.0 to 6.7) |
| Week 8 | 7.8 (6.9 to 8.7) | 6.7 (5.8 to 7.5) |
| Week 12 | 8.6 (7.6 to 9.5) | 7.7 (6.7 to 8.6) |
| Week 16 | 9.0 (7.9 to 10.1) | 8.3 (7.2 to 9.5) |
| Week 18 | 9.2 (8.0 to 10.3) | 9.2 (8.0 to 10.3) |
| Week 20 | 9.6 (8.4 to 10.8) | 9.4 (8.2 to 10.6) |
| Week 24 | 10.0 (8.8 to 11.2) | 8.7 (7.5 to 9.9) |
| Week 28 | 9.8 (8.6 to 11.1) | 9.4 (8.2 to 10.6) |
| Week 32 | 10.3 (9.1 to 11.5) | 8.9 (7.7 to 10.1) |
| Week 36 | 9.6 (8.4 to 10.9) | 9.4 (8.2 to 10.7) |
| Week 40 | 9.9 (8.7 to 11.2) | 9.2 (7.9 to 10.4) |
| Week 44 | 10.6 (9.3 to 11.8) | 9.5 (8.3 to 10.8) |
| Week 48 | 10.1 (8.8 to 11.3) | 9.6 (8.3 to 10.9) |
| Week 52 | 10.6 (9.3 to 11.9) | 9.4 (8.1 to 10.7) |
| Week 56 | 10.7 (9.3 to 12.0) | 9.5 (8.2 to 10.9) |
| Week 60 | 10.5 (9.1 to 11.9) | 9.3 (8.0 to 10.7) |
| Week 64 | 11.0 (9.7 to 12.3) | 9.5 (8.2 to 10.8) |
| Week 68 | 11.0 (9.6 to 12.3) | 9.5 (8.2 to 10.8) |
| Week 72 | 11.0 (9.6 to 12.3) | 9.4 (8.1 to 10.8) |
| Week 76 | 10.5 (9.2 to 11.8) | 9.8 (8.4 to 11.1) |
| Week 80 | 10.2 (8.9 to 11.6) | 9.4 (8.1 to 10.8) |
| Week 84 | 10.9 (9.4 to 12.4) | 8.9 (7.4 to 10.4) |
| Week 88 | 10.7 (9.1 to 12.4) | 8.6 (7.0 to 10.2) |
| Week 92 | 10.7 (9.1 to 12.2) | 9.3 (7.7 to 10.8) |
| Week 96 | 10.7 (9.1 to 12.3) | 8.5 (6.8 to 10.1) |
| Week 100 | 10.9 (9.3 to 12.6) | 8.4 (6.7 to 10.1) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 4 through Week 52, Week 4 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| period Week 4 through Week 52 | 9.1 (8.2 to 10.1) | 8.4 (7.4 to 9.3) |
| period Week 4 through Week 100 | 9.8 (8.8 to 10.9) | 8.7 (7.7 to 9.8) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the periods: Week 20 through Week 52, Week 20 through Week 100, Week 28 through Week 52, Week 28 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| period Week 20 through Week 52 | 10.1 (8.9 to 11.2) | 9.3 (8.1 to 10.4) |
| period Week 20 through Week 100 | 10.4 (9.2 to 11.7) | 9.2 (8.0 to 10.4) |
| period Week 28 through Week 52 | 10.1 (9.0 to 11.3) | 9.4 (8.2 to 10.5) |
| period Week 28 through Week 100 | 10.5 (9.3 to 11.7) | 9.2 (8.0 to 10.5) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. For each participants, this endpoint was defined as the mean change from baseline to the average value over the period Week 88 through Week 100. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Scores on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study Eye | 10.8 (9.2 to 12.3) | 8.7 (7.1 to 10.2) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 49.2 (41.6 to 56.7) | 46.4 (39.0 to 54.0) |
| Week 6 | 62.0 (54.5 to 69.1) | 62.4 (54.9 to 69.5) |
| Week 8 | 67.6 (60.2 to 74.4) | 63.5 (56.1 to 70.5) |
| Week 12 | 70.9 (63.7 to 77.5) | 73.5 (66.4 to 79.8) |
| Week 16 | 71.5 (64.3 to 78.0) | 73.5 (66.4 to 79.8) |
| Week 18 | 77.7 (70.8 to 83.5) | 77.9 (71.1 to 83.7) |
| Week 20 | 79.3 (72.7 to 85.0) | 76.2 (69.4 to 82.2) |
| Week 24 | 79.9 (73.3 to 85.5) | 77.9 (71.1 to 83.7) |
| Week 28 | 75.4 (68.4 to 81.5) | 77.9 (71.1 to 83.7) |
| Week 32 | 77.1 (70.2 to 83.0) | 80.7 (74.1 to 86.1) |
| Week 36 | 74.3 (67.2 to 80.5) | 80.7 (74.1 to 86.1) |
| Week 40 | 74.9 (67.8 to 81.0) | 79.6 (72.9 to 85.2) |
| Week 44 | 74.3 (67.2 to 80.5) | 80.7 (74.1 to 86.1) |
| Week 48 | 76.0 (69.0 to 82.0) | 79.0 (72.3 to 84.7) |
| Week 52 | 77.7 (70.8 to 83.5) | 79.0 (72.3 to 84.7) |
| Week 56 | 77.7 (70.8 to 83.5) | 80.7 (74.1 to 86.1) |
| Week 60 | 76.0 (69.0 to 82.0) | 79.0 (72.3 to 84.7) |
| Week 64 | 78.2 (71.4 to 84.0) | 79.0 (72.3 to 84.7) |
| Week 68 | 77.7 (70.8 to 83.5) | 76.8 (70.0 to 82.7) |
| Week 72 | 79.9 (73.3 to 85.5) | 77.3 (70.6 to 83.2) |
| Week 76 | 74.3 (67.2 to 80.5) | 77.3 (70.6 to 83.2) |
| Week 80 | 74.3 (67.2 to 80.5) | 75.7 (68.8 to 81.7) |
| Week 84 | 78.2 (71.4 to 84.0) | 73.5 (66.4 to 79.8) |
| Week 88 | 77.7 (70.8 to 83.5) | 75.7 (68.8 to 81.7) |
| Week 92 | 79.3 (72.7 to 85.0) | 74.0 (67.0 to 80.3) |
| Week 96 | 78.8 (72.0 to 84.5) | 73.5 (66.4 to 79.8) |
| Week 100 | 77.1 (70.2 to 83.0) | 73.5 (66.4 to 79.8) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 22.9 (17.0 to 29.8) | 23.8 (17.8 to 30.6) |
| Week 6 | 34.6 (27.7 to 42.1) | 31.5 (24.8 to 38.8) |
| Week 8 | 39.7 (32.4 to 47.2) | 36.5 (29.5 to 43.9) |
| Week 12 | 43.0 (35.7 to 50.6) | 45.9 (39.4 to 53.4) |
| Week 16 | 44.1 (36.7 to 51.7) | 49.7 (42.2 to 57.2) |
| Week 18 | 47.5 (40.0 to 55.1) | 53.0 (45.5 to 60.5) |
| Week 20 | 53.1 (45.5 to 60.6) | 56.9 (49.4 to 64.2) |
| Week 24 | 56.4 (48.8 to 63.8) | 53.6 (46.0 to 61.0) |
| Week 28 | 55.3 (47.7 to 62.7) | 55.2 (47.7 to 62.6) |
| Week 32 | 58.7 (51.1 to 66.0) | 51.9 (44.4 to 59.4) |
| Week 36 | 57.5 (49.9 to 64.9) | 55.2 (47.7 to 62.6) |
| Week 40 | 58.1 (50.5 to 65.4) | 52.5 (44.9 to 59.9) |
| Week 44 | 61.5 (53.9 to 68.6) | 56.9 (49.4 to 64.2) |
| Week 48 | 60.9 (53.3 to 68.1) | 53.0 (45.5 to 60.5) |
| Week 52 | 61.5 (53.9 to 68.6) | 58.6 (51.0 to 65.8) |
| Week 56 | 62.0 (54.5 to 69.1) | 54.1 (46.6 to 61.6) |
| Week 60 | 61.5 (53.9 to 68.6) | 54.7 (47.1 to 62.1) |
| Week 64 | 63.7 (56.2 to 70.7) | 56.9 (49.4 to 64.2) |
| Week 68 | 62.0 (54.5 to 69.1) | 57.5 (49.9 to 64.8) |
| Week 72 | 63.7 (56.2 to 70.7) | 56.4 (48.8 to 63.7) |
| Week 76 | 60.9 (53.3 to 68.1) | 56.9 (49.4 to 64.2) |
| Week 80 | 57.5 (49.9 to 64.9) | 55.8 (48.2 to 63.2) |
| Week 84 | 63.7 (56.2 to 70.7) | 58.6 (51.0 to 65.8) |
| Week 88 | 61.5 (53.9 to 68.6) | 58.0 (50.5 to 65.3) |
| Week 92 | 63.7 (56.2 to 70.7) | 58.6 (51.0 to 65.8) |
| Week 96 | 62.6 (55.0 to 69.7) | 56.9 (49.4 to 64.2) |
| Week 100 | 61.5 (53.9 to 68.6) | 54.1 (46.6 to 61.6) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 12.3 (7.9 to 18.0) | 9.4 (5.6 to 14.6) |
| Week 6 | 13.4 (8.8 to 19.3) | 13.8 (9.1 to 19.7) |
| Week 8 | 25.1 (19.0 to 32.2) | 16.0 (11.0 to 22.2) |
| Week 12 | 25.1 (19.0 to 32.2) | 22.1 (16.3 to 28.9) |
| Week 16 | 33.5 (26.7 to 40.9) | 25.4 (19.2 to 32.4) |
| Week 18 | 31.8 (25.1 to 39.2) | 33.1 (26.3 to 40.5) |
| Week 20 | 34.6 (27.7 to 42.1) | 32.6 (25.8 to 39.9) |
| Week 24 | 41.9 (34.6 to 49.5) | 30.9 (24.3 to 38.2) |
| Week 28 | 40.2 (33.0 to 47.8) | 37.0 (30.0 to 44.5) |
| Week 32 | 44.1 (36.7 to 51.7) | 30.4 (23.8 to 37.6) |
| Week 36 | 45.3 (37.8 to 52.8) | 32.6 (25.8 to 39.9) |
| Week 40 | 44.7 (37.3 to 52.3) | 31.5 (24.8 to 38.8) |
| Week 44 | 50.3 (42.7 to 57.8) | 35.4 (28.4 to 42.8) |
| Week 48 | 41.9 (34.6 to 49.5) | 37.0 (30.0 to 44.5) |
| Week 52 | 46.4 (38.9 to 54.0) | 37.6 (30.5 to 45.1) |
| Week 56 | 46.4 (38.9 to 54.0) | 35.9 (28.9 to 43.4) |
| Week 60 | 46.9 (39.4 to 54.5) | 38.7 (31.5 to 46.2) |
| Week 64 | 50.3 (42.7 to 57.8) | 36.5 (29.5 to 43.9) |
| Week 68 | 48.6 (41.1 to 56.2) | 35.9 (28.9 to 43.4) |
| Week 72 | 48.0 (40.5 to 55.6) | 35.4 (28.4 to 42.8) |
| Week 76 | 46.4 (38.9 to 54.0) | 40.9 (33.6 to 48.4) |
| Week 80 | 43.6 (36.2 to 51.2) | 37.6 (30.5 to 45.1) |
| Week 84 | 46.4 (38.9 to 54.0) | 37.0 (30.0 to 44.5) |
| Week 88 | 47.5 (40.0 to 55.1) | 40.9 (33.6 to 48.4) |
| Week 92 | 44.7 (37.3 to 52.3) | 40.3 (33.1 to 47.9) |
| Week 96 | 46.9 (39.4 to 54.5) | 38.1 (31.0 to 45.6) |
| Week 100 | 49.7 (42.2 to 57.3) | 37.6 (30.5 to 45.1) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 3.4 (1.2 to 7.2) | 4.4 (1.9 to 8.5) |
| Week 6 | 1.7 (0.3 to 4.8) | 3.3 (1.2 to 7.1) |
| Week 8 | 1.1 (0.1 to 4.0) | 2.8 (0.9 to 6.3) |
| Week 12 | 1.1 (0.1 to 4.0) | 2.2 (0.6 to 5.6) |
| Week 16 | 0.6 (0.0 to 3.1) | 2.2 (0.6 to 5.6) |
| Week 18 | 1.1 (0.1 to 4.0) | 1.1 (0.1 to 3.9) |
| Week 20 | 2.2 (0.6 to 5.6) | 2.8 (0.9 to 6.3) |
| Week 24 | 1.7 (0.3 to 4.8) | 3.3 (1.2 to 7.1) |
| Week 28 | 1.7 (0.3 to 4.8) | 2.2 (0.6 to 5.6) |
| Week 32 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 36 | 4.5 (1.9 to 8.6) | 1.1 (0.1 to 3.9) |
| Week 40 | 3.9 (1.6 to 7.9) | 2.2 (0.6 to 5.6) |
| Week 44 | 2.8 (0.9 to 6.4) | 2.2 (0.6 to 5.6) |
| Week 48 | 2.8 (0.9 to 6.4) | 2.8 (0.9 to 6.3) |
| Week 52 | 3.4 (1.2 to 7.2) | 3.3 (1.2 to 7.1) |
| Week 56 | 5.0 (2.3 to 9.3) | 3.3 (1.2 to 7.1) |
| Week 60 | 3.9 (1.6 to 7.9) | 4.4 (1.9 to 8.5) |
| Week 64 | 2.8 (0.9 to 6.4) | 3.3 (1.2 to 7.1) |
| Week 68 | 3.9 (1.6 to 7.9) | 2.8 (0.9 to 6.3) |
| Week 72 | 4.5 (1.9 to 8.6) | 5.0 (2.3 to 9.2) |
| Week 76 | 3.4 (1.2 to 7.2) | 4.4 (1.9 to 8.5) |
| Week 80 | 2.8 (0.9 to 6.4) | 6.1 (3.1 to 10.6) |
| Week 84 | 3.4 (1.2 to 7.2) | 7.7 (4.3 to 12.6) |
| Week 88 | 3.9 (1.6 to 7.9) | 7.2 (3.9 to 12.0) |
| Week 92 | 3.4 (1.2 to 7.2) | 6.6 (3.5 to 11.3) |
| Week 96 | 3.9 (1.6 to 7.9) | 7.2 (3.9 to 12.0) |
| Week 100 | 2.8 (0.9 to 6.4) | 8.3 (4.7 to 13.3) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | NA (NA to NA) | 1.1 (0.1 to 3.9) |
| Week 6 | 1.1 (0.1 to 4.0) | 0.6 (0.0 to 3.0) |
| Week 8 | 1.1 (0.1 to 4.0) | NA (NA to NA) |
| Week 12 | NA (NA to NA) | 0.6 (0.0 to 3.0) |
| Week 16 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 18 | 1.1 (0.1 to 4.0) | NA (NA to NA) |
| Week 20 | 1.7 (0.3 to 4.8) | NA (NA to NA) |
| Week 24 | 1.7 (0.3 to 4.8) | 1.1 (0.1 to 3.9) |
| Week 28 | 1.7 (0.3 to 4.8) | NA (NA to NA) |
| Week 32 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 36 | 3.4 (1.2 to 7.2) | NA (NA to NA) |
| Week 40 | 2.8 (0.9 to 6.4) | NA (NA to NA) |
| Week 44 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 48 | 2.2 (0.6 to 5.6) | 0.6 (0.0 to 3.0) |
| Week 52 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 56 | 2.2 (0.6 to 5.6) | 1.1 (0.1 to 3.9) |
| Week 60 | 1.7 (0.3 to 4.8) | 1.7 (0.3 to 4.8) |
| Week 64 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 68 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 72 | 2.2 (0.6 to 5.6) | 1.7 (0.3 to 4.8) |
| Week 76 | 2.2 (0.6 to 5.6) | 0.6 (0.0 to 3.0) |
| Week 80 | 1.7 (0.3 to 4.8) | 1.7 (0.3 to 4.8) |
| Week 84 | 2.2 (0.6 to 5.6) | 4.4 (1.9 to 8.5) |
| Week 88 | 2.8 (0.9 to 6.4) | 3.9 (1.6 to 7.8) |
| Week 92 | 2.8 (0.9 to 6.3) | 2.8 (0.9 to 6.3) |
| Week 96 | 2.2 (0.6 to 5.6) | 3.9 (1.6 to 7.8) |
| Week 100 | 2.2 (0.6 to 5.6) | 6.1 (3.1 to 10.6) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | NA (NA to NA) | 0.6 (0.0 to 3.0) |
| Week 6 | 1.1 (0.1 to 4.0) | NA (NA to NA) |
| Week 8 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 12 | NA (NA to NA) | 0.6 (0.0 to 3.0) |
| Week 16 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 18 | 1.1 (0.1 to 4.0) | NA (NA to NA) |
| Week 20 | 1.7 (0.3 to 4.8) | NA (NA to NA) |
| Week 24 | 1.1 (0.1 to 4.0) | 0.6 (0.0 to 3.0) |
| Week 28 | 1.7 (0.3 to 4.8) | NA (NA to NA) |
| Week 32 | 1.7 (0.3 to 4.8) | NA (NA to NA) |
| Week 36 | 2.8 (0.9 to 6.4) | NA (NA to NA) |
| Week 40 | 2.2 (0.6 to 5.6) | NA (NA to NA) |
| Week 44 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 48 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 52 | 1.1 (0.1 to 4.0) | 1.7 (0.3 to 4.8) |
| Week 56 | 1.7 (0.3 to 4.8) | 1.1 (0.1 to 3.9) |
| Week 60 | 1.7 (0.3 to 4.8) | 1.7 (0.3 to 4.8) |
| Week 64 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 68 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 72 | 2.2 (0.6 to 5.6) | 1.1 (0.1 to 3.9) |
| Week 76 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 80 | 1.7 (0.3 to 4.8) | 0.6 (0.0 to 3.0) |
| Week 84 | 1.7 (0.3 to 4.8) | 2.2 (0.6 to 5.6) |
| Week 88 | 1.7 (0.3 to 4.8) | 2.2 (0.6 to 5.6) |
| Week 92 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 96 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 100 | 2.2 (0.6 to 5.6) | 3.3 (1.2 to 7.1) |
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The overall BCVA score (number of letters read correctly by the patient) was calculated using the BCVA worksheet 0-100 letter score, with higher score indicating improvement in acuity. A positive change from baseline is a favorable outcome. BCVA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 55.3 (47.7 to 62.7) | 42.5 (35.2 to 50.1) |
| Week 6 | 64.8 (57.3 to 71.8) | 49.7 (42.2 to 57.2) |
| Week 8 | 66.5 (59.1 to 73.3) | 50.8 (43.3 to 58.3) |
| Week 12 | 66.5 (59.1 to 73.3) | 59.7 (52.1 to 66.9) |
| Week 16 | 69.8 (62.5 to 76.5) | 60.8 (53.3 to 67.9) |
| Week 18 | 71.5 (64.3 to 78.0) | 64.6 (57.2 to 71.6) |
| Week 20 | 71.5 (64.3 to 78.0) | 61.3 (53.8 to 68.5) |
| Week 24 | 73.2 (66.1 to 79.5) | 60.2 (52.7 to 67.4) |
| Week 28 | 72.6 (65.5 to 79.0) | 61.9 (54.4 to 69.0) |
| Week 32 | 73.7 (66.7 to 80.0) | 59.1 (51.6 to 66.4) |
| Week 36 | 70.4 (63.1 to 77.0) | 65.2 (57.8 to 72.1) |
| Week 40 | 69.8 (62.5 to 76.5) | 60.2 (52.7 to 67.4) |
| Week 44 | 73.7 (66.7 to 80.0) | 63.5 (56.1 to 70.5) |
| Week 48 | 70.9 (63.7 to 77.5) | 61.3 (53.8 to 68.5) |
| Week 52 | 73.7 (66.7 to 80.0) | 64.6 (57.2 to 71.6) |
| Week 56 | 72.6 (65.5 to 79.0) | 66.9 (59.5 to 73.7) |
| Week 60 | 70.9 (63.7 to 77.5) | 66.9 (59.5 to 73.7) |
| Week 64 | 74.3 (67.2 to 80.5) | 68.5 (61.2 to 75.2) |
| Week 68 | 71.5 (64.3 to 78.0) | 66.3 (58.9 to 73.1) |
| Week 72 | 73.7 (66.7 to 80.0) | 65.2 (57.8 to 72.1) |
| Week 76 | 72.6 (65.5 to 79.0) | 66.9 (59.5 to 73.7) |
| Week 80 | 70.9 (63.7 to 77.5) | 64.1 (56.6 to 71.1) |
| Week 84 | 70.9 (63.7 to 77.5) | 65.2 (57.8 to 72.1) |
| Week 88 | 72.6 (65.5 to 79.0) | 63.5 (56.1 to 70.5) |
| Week 92 | 71.5 (64.3 to 78.0) | 63.5 (56.1 to 70.5) |
| Week 96 | 70.4 (63.1 to 77.0) | 62.4 (54.9 to 69.5) |
| Week 100 | 70.9 (63.7 to 77.5) | 62.4 (54.9 to 69.5) |
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Micrometers | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | -128.2 ± 131.47 | -113.9 ± 123.20 |
| Week 6 | -136.9 ± 135.57 | -126.0 ± 124.82 |
| Week 8 | -155.4 ± 139.09 | -130.8 ± 124.71 |
| Week 12 | -160.8 ± 137.23 | -137.9 ± 132.30 |
| Week 16 | -179.1 ± 137.26 | -145.3 ± 132.63 |
| Week 18 | -175.8 ± 139.10 | -149.0 ± 132.28 |
| Week 20 | -183.7 ± 139.76 | -151.0 ± 130.98 |
| Week 24 | -183.3 ± 143.14 | -134.0 ± 136.67 |
| Week 28 | -192.0 ± 145.85 | -161.4 ± 131.27 |
| Week 32 | -178.6 ± 138.5 | -144.9 ± 135.93 |
| Week 36 | -163.5 ± 144.34 | -162.9 ± 135.19 |
| Week 40 | -183.3 ± 139.84 | -149.9 ± 132.66 |
| Week 44 | -193.3 ± 144.12 | -163.5 ± 133.01 |
| Week 48 | -172.8 ± 141.83 | -154.6 ± 130.54 |
| Week 52 | -196.5 ± 144.44 | -165.0 ± 134.77 |
| Week 56 | -191.08 ± 148.02 | -162.4 ± 132.53 |
| Week 60 | -189.8 ± 147.93 | -166.2 ± 132.61 |
| Week 64 | -193.2 ± 143.36 | -160.2 ± 137.83 |
| Week 68 | -194.5 ± 141.47 | -169.8 ± 143.97 |
| Week 72 | -190.4 ± 142.25 | -165.1 ± 141.38 |
| Week 76 | -185.6 ± 143.68 | -174.7 ± 138.70 |
| Week 80 | -185.7 ± 145.52 | -171.1 ± 138.53 |
| Week 84 | -193.5 ± 142.53 | -175.1 ± 139.76 |
| Week 88 | -191.0 ± 141.29 | -172.2 ± 138.08 |
| Week 92 | -193.8 ± 142.07 | -180.1 ± 138.88 |
| Week 96 | -197.2 ± 144.29 | -170.2 ± 154.37 |
| Week 100 | -201.4 ± 142.90 | -173.9 ± 152.03 |
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment. For each participants, this endpoint was derived as the average of the changes from Baseline to Weeks 40, 44, 48, 52. Then the same was derived over the period Week 88 through Week 100, considering the average of the changes from Baseline to Weeks 88, 92, 96, 100. This endpoint was only assessed in the year-2 analysis (Week 100).
| Micrometers | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| period Week 40 through Week 52 | -187.1 (-200.7 to -173.5) | -157.7 (-171.2 to -144.1) |
| period Week 88 through Week 100 | -196.6 (-210.9 to -182.3) | -173.4 (-187.6 to -159.1) |
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. a negative change from baseline indicates a reduction in thickness, whereas a positive change from baseline indicates an increase. An increase in thickness may indicate a progression of the underlying disease. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Micrometers | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| period Week 4 through Week 52 | -172.8 (-185.8 to -159.8) | -145.4 (-158.4 to -132.4) |
| period Week 4 through Week 100 | -181.8 (-194.7 to -168.9) | -156.1 (-169.0 to -143.2) |
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. CSFT assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 12.8 (8.3 to 18.7) | 13.3 (8.7 to 19.2) |
| Week 6 | 16.8 (11.6 to 23.1) | 14.4 (9.7 to 20.4) |
| Week 8 | 22.9 (17.0 to 29.8) | 16.7 (11.5 to 22.9) |
| Week 12 | 30.2 (23.5 to 37.5) | 24.4 (18.4 to 31.4) |
| Week 16 | 36.9 (29.8 to 44.4) | 29.4 (22.9 to 36.7) |
| Week 18 | 39.1 (31.9 to 46.7) | 30.0 (23.4 to 37.3) |
| Week 20 | 42.5 (35.1 to 50.1) | 31.1 (24.4 to 38.4) |
| Week 24 | 48.6 (41.1 to 56.2) | 29.4 (22.9 to 36.7) |
| Week 28 | 50.3 (42.7 to 57.8) | 33.9 (27.0 to 41.3) |
| Week 32 | 48.0 (40.5 to 55.6) | 30.6 (23.9 to 37.8) |
| Week 36 | 38.5 (31.4 to 46.1) | 38.9 (31.7 to 46.4) |
| Week 40 | 51.4 (43.8 to 58.9) | 37.2 (30.1 to 44.7) |
| Week 44 | 51.4 (43.8 to 58.9) | 38.9 (31.7 to 46.4) |
| Week 48 | 49.7 (42.2 to 57.3) | 37.2 (30.1 to 44.7) |
| Week 52 | 57.5 (49.9 to 64.9) | 41.4 (34.2 to 49.0) |
| Week 56 | 57.5 (49.9 to 64.9) | 40.3 (33.1 to 47.9) |
| Week 60 | 53.1 (45.5 to 60.6) | 40.3 (33.1 to 47.9) |
| Week 64 | 54.2 (46.6 to 61.6) | 38.1 (31.0 to 45.6) |
| Week 68 | 53.6 (46.0 to 61.1) | 41.4 (34.2 to 49.0) |
| Week 72 | 56.4 (48.8 to 63.8) | 38.7 (31.5 to 46.2) |
| Week 76 | 55.3 (47.7 to 62.7) | 42.5 (35.2 to 50.1) |
| Week 80 | 57.0 (49.4 to 64.3) | 39.8 (32.6 to 47.3) |
| Week 84 | 57.0 (49.4 to 64.3) | 43.1 (35.8 to 50.6) |
| Week 88 | 56.4 (48.8 to 63.8) | 41.4 (34.2 to 49.0) |
| Week 92 | 57.0 (49.4 to 64.3) | 45.9 (38.4 to 53.4) |
| Week 96 | 59.8 (52.2 to 67.0) | 43.6 (36.3 to 51.2) |
| Week 100 | 62.0 (54.5 to 69.1) | 47.0 (39.5 to 54.5) |
Presence of Subretinal Fluid (SRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Subretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 12.3 (7.9 to 18.0) | 19.3 (13.9 to 25.9) |
| Week 6 | 10.1 (6.1 to 15.4) | 13.8 (9.1 to 19.7) |
| Week 8 | 5.6 (2.7 to 10.0) | 12.2 (7.8 to 17.8) |
| Week 12 | 3.9 (1.6 to 7.9) | 7.7 (4.3 to 12.6) |
| Week 16 | 1.7 (0.3 to 4.8) | 3.9 (1.6 to 7.8) |
| Week 18 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 20 | 1.7 (0.3 to 4.8) | 3.3 (1.2 to 7.1) |
| Week 24 | 2.2 (0.6 to 5.6) | 6.6 (3.5 to 11.3) |
| Week 28 | 2.2 (0.6 to 5.6) | 2.8 (0.9 to 6.3) |
| Week 32 | 5.0 (2.3 to 9.3) | 3.9 (1.6 to 7.8) |
| Week 36 | 6.7 (3.5 to 11.4) | 1.7 (0.3 to 4.8) |
| Week 40 | 4.5 (1.9 to 8.6) | 2.8 (0.9 to 6.3) |
| Week 44 | 2.2 (0.6 to 5.6) | 2.8 (0.9 to 6.3) |
| Week 48 | 6.1 (3.1 to 10.7) | 5.0 (2.3 to 9.2) |
| Week 52 | 1.7 (0.3 to 4.8) | 3.3 (1.2 to 7.1) |
| Week 56 | 2.8 (0.9 to 6.4) | 2.2 (0.6 to 5.6) |
| Week 60 | 2.8 (0.9 to 6.4) | 2.2 (0.6 to 5.6) |
| Week 64 | 2.2 (0.6 to 5.6) | 3.9 (1.6 to 7.8) |
| Week 68 | 3.4 (1.2 to 7.2) | 4.4 (1.9 to 8.5) |
| Week 72 | 3.4 (1.2 to 7.2) | 2.8 (0.9 to 6.3) |
| Week 76 | 3.9 (1.6 to 7.9) | 2.2 (0.6 to 5.6) |
| Week 80 | 4.5 (1.9 to 8.6) | 2.2 (0.6 to 5.6) |
| Week 84 | 2.2 (0.6 to 5.6) | 2.2 (0.6 to 5.6) |
| Week 88 | 3.4 (1.2 to 7.2) | 2.2 (0.6 to 5.6) |
| Week 92 | 1.7 (0.3 to 4.8) | 1.1 (0.1 to 3.9) |
| Week 96 | 2.2 (0.6 to 5.6) | 2.8 (0.9 to 6.3) |
| Week 100 | 2.2 (0.6 to 5.6) | 2.8 (0.9 to 6.3) |
Presence of Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Intraretinal fluid status assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 88.3 (82.6 to 92.6) | 89.0 (83.5 to 93.1) |
| Week 6 | 85.5 (79.4 to 90.3) | 86.2 (80.3 to 90.9) |
| Week 8 | 87.2 (81.3 to 91.7) | 84.5 (78.4 to 89.5) |
| Week 12 | 83.8 (77.6 to 88.9) | 85.6 (79.7 to 90.4) |
| Week 16 | 76.0 (69.0 to 82.0) | 84.0 (77.8 to 89.0) |
| Week 18 | 77.7 (70.8 to 83.5) | 81.2 (74.8 to 86.6) |
| Week 20 | 72.6 (65.5 to 79.0) | 79.6 (72.9 to 85.2) |
| Week 24 | 69.8 (62.5 to 76.5) | 82.3 (76.0 to 87.6) |
| Week 28 | 67.6 (60.2 to 74.4) | 75.1 (68.2 to 81.3) |
| Week 32 | 67.6 (60.2 to 74.4) | 76.8 (70.0 to 82.7) |
| Week 36 | 73.2 (66.1 to 79.5) | 72.4 (65.3 to 78.7) |
| Week 40 | 57.5 (49.9 to 64.9) | 74.0 (67.0 to 80.3) |
| Week 44 | 56.4 (48.8 to 63.8) | 71.3 (64.1 to 77.7) |
| Week 48 | 60.9 (53.3 to 68.1) | 75.7 (68.8 to 81.7) |
| Week 52 | 53.6 (46.0 to 61.1) | 72.9 (65.8 to 79.3) |
| Week 56 | 51.4 (43.8 to 58.9) | 70.2 (62.9 to 76.7) |
| Week 60 | 55.3 (47.7 to 62.7) | 69.1 (61.8 to 75.7) |
| Week 64 | 48.6 (41.1 to 56.2) | 69.6 (62.4 to 76.2) |
| Week 68 | 47.5 (40.0 to 55.1) | 66.9 (59.5 to 73.7) |
| Week 72 | 45.8 (38.4 to 53.4) | 66.9 (59.5 to 73.7) |
| Week 76 | 50.3 (42.7 to 57.8) | 63.0 (55.5 to 70.0) |
| Week 80 | 45.8 (38.4 to 53.4) | 65.7 (58.3 to 72.6) |
| Week 84 | 40.2 (33.0 to 47.8) | 63.0 (55.5 to 70.0) |
| Week 88 | 48.0 (40.5 to 55.6) | 64.1 (56.6 to 71.1) |
| Week 92 | 44.7 (37.3 to 52.3) | 59.1 (51.6 to 66.4) |
| Week 96 | 41.3 (34.0 to 48.9) | 61.9 (54.4 to 69.0) |
| Week 100 | 40.8 (33.5 to 48.4) | 56.9 (49.4 to 64.2) |
Presence of Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) in the study eye was assessed by spectral domain optical coherence tomography (SD-OCT), angiography, and/or color fundus photography. Fluid status (SRF and/or IRF) assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 4 | 90.5 (85.2 to 94.4) | 90.6 (85.4 to 94.4) |
| Week 6 | 86.6 (80.7 to 91.2) | 88.4 (82.8 to 92.7) |
| Week 8 | 87.2 (81.3 to 91.7) | 85.6 (79.7 to 90.4) |
| Week 12 | 83.8 (77.6 to 88.9) | 86.2 (80.3 to 90.9) |
| Week 16 | 76.0 (69.0 to 82.0) | 84.0 (77.8 to 89.0) |
| Week 18 | 78.2 (71.4 to 84.0) | 81.2 (74.8 to 86.6) |
| Week 20 | 73.2 (66.1 to 79.5) | 79.6 (72.9 to 85.2) |
| Week 24 | 70.4 (63.1 to 77.0) | 82.3 (76.0 to 87.6) |
| Week 28 | 68.7 (61.4 to 75.4) | 75.1 (68.2 to 81.3) |
| Week 32 | 68.7 (61.4 to 75.4) | 76.8 (70.0 to 82.7) |
| Week 36 | 73.7 (66.7 to 80.0) | 72.4 (65.3 to 78.7) |
| Week 40 | 58.1 (50.5 to 65.4) | 74.0 (67.0 to 80.3) |
| Week 44 | 57.0 (49.4 to 64.3) | 71.3 (64.1 to 77.7) |
| Week 48 | 61.5 (53.9 to 68.6) | 75.7 (68.8 to 81.7) |
| Week 52 | 54.2 (46.6 to 61.6) | 72.9 (65.8 to 79.3) |
| Week 56 | 52.0 (44.4 to 59.5) | 70.2 (62.9 to 76.7) |
| Week 60 | 55.3 (47.7 to 62.7) | 69.1 (61.8 to 75.7) |
| Week 64 | 49.2 (41.6 to 56.7) | 69.6 (62.4 to 76.2) |
| Week 68 | 48.0 (40.5 to 55.6) | 68.0 (60.6 to 74.7) |
| Week 72 | 46.9 (39.4 to 54.5) | 66.9 (59.5 to 73.7) |
| Week 76 | 50.8 (43.3 to 58.4) | 63.0 (55.5 to 70.0) |
| Week 80 | 46.4 (38.9 to 54.0) | 65.7 (58.3 to 72.6) |
| Week 84 | 40.8 (33.5 to 48.4) | 63.0 (55.5 to 70.0) |
| Week 88 | 48.6 (41.1 to 56.2) | 64.1 (56.6 to 71.1) |
| Week 92 | 45.3 (37.8 to 52.8) | 59.1 (51.6 to 66.4) |
| Week 96 | 41.3 (34.0 to 48.9) | 61.9 (54.4 to 69.0) |
| Week 100 | 40.8 (33.5 to 48.4) | 56.9 (49.4 to 64.2) |
Presence of leakage on Fluorescein Angiography as assessed by fluorescein angiography. Leakage on FA assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 52 | 54.7 (47.2 to 62.2) | 79.4 (72.8 to 85.1) |
| Week 100 | 46.9 (39.4 to 54.5) | 65.6 (58.1 to 72.5) |
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 25.0 (18.8 to 32.1) | 20.9 (15.2 to 27.6) |
| Week 52 | 29.0 (22.4 to 36.3) | 27.7 (21.2 to 34.9) |
| Week 76 | 30.1 (23.4 to 37.5) | 30.5 (23.8 to 37.9) |
| Week 100 | 35.8 (28.7 to 43.4) | 31.1 (24.3 to 38.5) |
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 13.1 (8.5 to 19.0) | 11.3 (7.0 to 16.9) |
| Week 52 | 14.8 (9.9 to 20.9) | 15.3 (10.3 to 21.4) |
| Week 76 | 18.8 (13.3 to 25.3) | 15.3 (10.3 to 21.4) |
| Week 100 | 21.0 (15.3 to 27.8) | 16.9 (11.7 to 23.3) |
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 2.3 (0.6 to 5.7) | 0.6 (0.0 to 3.1) |
| Week 52 | 1.7 (0.4 to 4.9) | 0.6 (0.0 to 3.1) |
| Week 76 | 3.4 (1.3 to 7.3) | 0.6 (0.0 to 3.1) |
| Week 100 | 4.5 (2.0 to 8.8) | 1.7 (0.4 to 4.9) |
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 52 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 76 | 0.6 (0.0 to 3.1) | NA (NA to NA) |
| Week 100 | 0.6 (0.0 to 3.1) | 1.1 (0.1 to 4.0) |
The Diabetic Retinopathy Disease Severity Scale was based on 7-field stereo color fundus photography and measured 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. DRSS assessments after start of alternative diabetic macular edema (DME) treatment in the study eye were censored and replaced by the last value prior to start of this alternative treatment.
| Percentage of Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Percentage of Participants With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS-DRSS Score of at Least 61 by Week 100 | 0.6 (0.0 to 3.4) | 0.6 (0.0 to 3.4) |
The number of participants with ocular and non-ocular adverse events was was assessed by CTCAE and reported categorically: Mild, Moderate, Severe.
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Ocular adverse events — Mild | 52 | 47 |
| Ocular adverse events — Moderate | 15 | 23 |
| Ocular adverse events — Severe | 6 | 4 |
| Non-ocular adverse events — Mild | 52 | 51 |
| Non-ocular adverse events — Moderate | 51 | 50 |
| Non-ocular adverse events — Severe | 33 | 40 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 5.7 ± 11.91 | 6.3 ± 10.19 |
| Week 52 | 8.9 ± 11.67 | 6.7 ± 12.12 |
| Week 76 | 9.8 ± 12.22 | 7.6 ± 11.81 |
| Week 100 | 9.0 ± 12.94 | 6.2 ± 14.13 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 9.0 ± 16.11 | 10.2 ± 15.63 |
| Week 52 | 11.2 ± 17.05 | 10.5 ± 17.14 |
| Week 76 | 12.4 ± 16.49 | 12.0 ± 16.40 |
| Week 100 | 12.0 ± 16.25 | 10.1 ± 18.73 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 4.1 ± 19.52 | 4.6 ± 18.48 |
| Week 52 | 4.6 ± 18.75 | 4.4 ± 17.92 |
| Week 76 | 6.2 ± 16.95 | 4.6 ± 18.68 |
| Week 100 | 4.3 ± 16.60 | 5.4 ± 20.77 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 6.4 ± 20.83 | 6.3 ± 18.42 |
| Week 52 | 10.5 ± 20.30 | 9.3 ± 19.57 |
| Week 76 | 11.0 ± 21.91 | 9.2 ± 18.76 |
| Week 100 | 13.0 ± 20.21 | 7.3 ± 21.71 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 6.2 ± 18.87 | 5.6 ± 15.78 |
| Week 52 | 11.7 ± 17.62 | 8.2 ± 17.12 |
| Week 76 | 12.1 ± 18.32 | 8.1 ± 16.71 |
| Week 100 | 11.4 ± 18.94 | 6.6 ± 19.07 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 3.3 ± 15.82 | 4.4 ± 16.48 |
| Week 52 | 7.1 ± 16.22 | 4.9 ± 15.59 |
| Week 76 | 6.3 ± 16.65 | 5.0 ± 15.34 |
| Week 100 | 6.1 ± 16.78 | 4.1 ± 17.55 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 7.9 ± 19.53 | 10.1 ± 19.90 |
| Week 52 | 12.6 ± 22.42 | 10.1 ± 22.78 |
| Week 76 | 13.5 ± 21.02 | 13.1 ± 23.10 |
| Week 100 | 13.3 ± 20.91 | 11.6 ± 26.31 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 6.9 ± 25.13 | 9.4 ± 23.41 |
| Week 52 | 12.2 ± 24.76 | 8.7 ± 27.21 |
| Week 76 | 14.0 ± 28.44 | 11.4 ± 27.83 |
| Week 100 | 12.3 ± 28.14 | 10.2 ± 27.12 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 5.5 ± 19.39 | 3.6 ± 20.34 |
| Week 52 | 7.6 ± 19.53 | 3.9 ± 22.49 |
| Week 76 | 7.3 ± 20.19 | 5.6 ± 23.24 |
| Week 100 | 6.8 ± 19.85 | 2.9 ± 24.79 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 1.4 ± 18.75 | 4.8 ± 12.24 |
| Week 52 | 6.4 ± 14.63 | 4.2 ± 12.81 |
| Week 76 | 8.9 ± 15.95 | 2.8 ± 15.88 |
| Week 100 | 5.4 ± 15.81 | 1.2 ± 16.75 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 3.5 ± 15.10 | 4.2 ± 12.50 |
| Week 52 | 5.8 ± 15.08 | 3.6 ± 13.09 |
| Week 76 | 5.2 ± 15.73 | 3.9 ± 13.79 |
| Week 100 | 4.3 ± 14.70 | 3.2 ± 15.48 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 5.3 ± 18.83 | 4.0 ± 16.99 |
| Week 52 | 7.2 ± 18.68 | 3.2 ± 19.77 |
| Week 76 | 9.3 ± 19.64 | 4.3 ± 17.82 |
| Week 100 | 8.5 ± 19.33 | 2.3 ± 19.37 |
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicated the best possible response. The composite score and score of each construct also ranged from 0 to 100 as they were calculated as total scores divided by the number of questions. The higher the values of total scores represented better outcome.
| Score on a scale | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Week 28 | 3.9 ± 18.66 | 4.3 ± 19.92 |
| Week 52 | 5.8 ± 22.34 | 4.8 ± 23.12 |
| Week 76 | 8.9 ± 21.21 | 7.1 ± 22.57 |
| Week 100 | 6.7 ± 19.14 | 5.7 ± 21.80 |
Serum samples were taken approximately 24 hours after the first dose and 24 hours after the treatment at Week 24 to confirm the systemic brolucizumab exposure in patients with visual impairment due to diabetic macular edema.
| ng/mL | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Day 2 | 56.2 ± 10.4 | — |
| Week 4 | 0.760 ± 1.98 | — |
| Week 12 | NA ± NA | — |
| Week 24 | NA ± NA | — |
| Week 24 + 1 Day | 41.5 ± 80.5 | — |
Integrated ADA Status was categorized: ADA negative or ADA positive with no boost, Induced or Boosted, Missing ADA at pre-dose or no post-dose ADA data. * ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points. * ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point. * Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point. * Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| ADA negative or ADA positive with no boost | 146 | — |
| Induced or Boosted | 27 | — |
| Missing ADA at pre-dose or no post-dose ADA data | 6 | — |
Integrated ADA Status - adjusted for pre-existing ADA status was categorized: ADA negative, ADA positive with no boost, Induced, Boosted. * ADA negative: (a) ADA negative at all time points (pre-dose and post-dose), (b) ADA negative at pre-dose and no titer values above 40 at all other time points, (c) ADA titer of 40 at pre-dose but negative at all other time points. * ADA positive with no boost: ADA positive at pre-dose, post-dose titer values do not increase from pre-dose by more than 3-fold (1 dilution) at any time point. * Induced: ADA negative at pre-dose, post-dose titer value of 120 or more at any time point. * Boosted: ADA positive at pre-dose, post-dose titer values increase from pre-dose by more than 3-fold (1 dilution) at any time point.
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| ADA negative/ADA Negative or titer value of 40 at pre-dose | 53 | — |
| ADA positive with no boost/ADA Positive at pre-dose | 93 | — |
| Induced/ADA Negative at pre-dose | 14 | — |
| Boosted/ADA Positive at pre-dose | 13 | — |
Pre-existing ADA status and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: Negative, Positive.
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Negative — At least 1 AESI | 1 | — |
| Negative — No AESI | 63 | — |
| Postive — At least 1 AESI | 5 | — |
| Postive — No AESI | 105 | — |
Integrated ADA status up to Week 100 and incidence of Adverse Event of Special Interest (AESI) in the study eye was categorized: ADA-negative or no boost, Induced or boosted.
| Participants | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| ADA-negative or no boost — At least 1 AESI | 4 | — |
| ADA-negative or no boost — No AESI | 142 | — |
| Induced or boosted — At least 1 AESI | 2 | — |
| Induced or boosted — No AESI | 25 | — |
Collected over From first dose of study treatment up to 30 days after last dose (maximum 35 months). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brolucizumab 6mg | 13/179 (7.3%) | 53/179 (29.6%) | 131/179 (73.2%) |
| Aflibercept 2mg | 9/181 (5%) | 60/181 (33.1%) | 134/181 (74%) |
| Overall | 22/360 (6.1%) | 113/360 (31.4%) | 265/360 (73.6%) |
| Event | Brolucizumab 6mg | Aflibercept 2mg | Overall |
|---|---|---|---|
| COVID-19Infections and infestations | 4/179 | 3/181 | 7/360 |
| PneumoniaInfections and infestations | 4/179 | 3/181 | 7/360 |
| Cardiac failureCardiac disorders | 2/179 | 4/181 | 6/360 |
| GangreneInfections and infestations | 3/179 | 2/181 | 5/360 |
| Myocardial infarctionCardiac disorders | 0/179 | 3/181 | 3/360 |
| Chronic kidney diseaseRenal and urinary disorders | 0/179 | 3/181 | 3/360 |
| Angina pectorisCardiac disorders | 2/179 | 0/181 | 2/360 |
| Coronary artery stenosisCardiac disorders | 2/179 | 1/181 | 3/360 |
| Rectal haemorrhageGastrointestinal disorders | 2/179 | 0/181 | 2/360 |
| Endophthalmitis - Study eyeInfections and infestations | 2/179 | 1/181 | 3/360 |
| Event | Brolucizumab 6mg | Aflibercept 2mg | Overall |
|---|---|---|---|
| Cataract - Study eyeEye disorders | 12/179 | 19/181 | 31/360 |
| Diabetic retinal oedema - Fellow eyeEye disorders | 18/179 | 16/181 | 34/360 |
| NasopharyngitisInfections and infestations | 16/179 | 17/181 | 33/360 |
| HypertensionVascular disorders | 15/179 | 17/181 | 32/360 |
| Cataract - Fellow eyeEye disorders | 11/179 | 16/181 | 27/360 |
| ProteinuriaRenal and urinary disorders | 6/179 | 13/181 | 19/360 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/179 | 10/181 | 15/360 |
| Conjunctival haemorrhage - Study eyeEye disorders | 9/179 | 6/181 | 15/360 |
| Dry eye - Fellow eyeEye disorders | 9/179 | 7/181 | 16/360 |
| Dry eye - Study eyeEye disorders | 9/179 | 9/181 | 18/360 |
| Age, Continuous(Years) | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Mean | 62.3 ± 10.55 | 62.2 ± 9.48 | 62.2 ± 10.01 |
| Age, Customized(Participants) | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| < 65 years | 100 | 102 | 202 |
| >= 65 years | 79 | 79 | 158 |
| Sex: Female, Male(Participants) | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Female | 59 | 66 | 125 |
| Male | 120 | 115 | 235 |
| Ethnicity (NIH/OMB)(Participants) | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 163 | 170 | 333 |
| Unknown or Not Reported | 13 | 7 | 20 |
| Race (NIH/OMB)(Participants) | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 43 | 48 | 91 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 133 | 132 | 265 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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 Jun 2020, 23 months.
Results were first posted in Jan 2024, 3 years 6 months after primary completion.
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 23 months is close to 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 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brolucizumab