18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study EyePrimary· Baseline, Week 52
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 di
Group
Value
95% CI
Brolucizumab 6 mg
10.6
9.3 – 11.9
Aflibercept 2 mg
9.4
8.1 – 10.7
Average Mean Change From Baseline in BCVA Over the Period Week 40 Through Week 52 for the Study EyeSecondary· Baseline, period Week 40 through Week 52
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 defin
Group
Value
95% CI
Brolucizumab 6 mg
10.3
9.1 – 11.5
Aflibercept 2 mg
9.4
8.2 – 10.6
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 and up to q12w/q16w up to Week 100.Secondary· Week 52, 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 \[every 12 weeks (q12w)\].
Week 48
Group
Value
95% CI
Brolucizumab 6 mg
50.3
42.5 – 57.7
Week 96
Group
Value
95% CI
Brolucizumab 6 mg
36.8
29.1 – 45.5
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w up to Week 52 Within Those Patients That Qualified for q12w at Week 36Secondary· Week 36, Week 52
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 \[every 12 weeks (q12w)\].
Group
Value
95% CI
Brolucizumab 6 mg
95.1
87.4 – 98.1
(Brolucizumab Treatment Arm Only): Percentage of Participants Maintained at q12w/q16w up to Week 100, Within Those Patients That Qualified for q12w at Week 36Secondary· Week 36, Week 100
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
Group
Value
95% CI
Brolucizumab 6 mg
69.6
57.4 – 78.9
(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 76Secondary· Week 68, Week 76, Week 100
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
Group
Value
95% CI
Brolucizumab 6 mg
87.9
73.3 – 94.8
(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 80Secondary· Week 68, Week 80, Week 100
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
Group
Value
95% CI
Brolucizumab 6 mg
73.1
54.5 – 85.0
(Brolucizumab Treatment Arm Only): Number of Participants With Injections Per Planned Dosing Regimen (Every 8, 12 or 16 Weeks)Secondary· Week 100
Reported categorically for the subjects who completed the study treatment period: every 8 weeks (q8w), Every 12 weeks (q12w), Every 16 weeks (q16w)
Group
Value
95% CI
Brolucizumab 6 mg
74
Brolucizumab 6 mg
32
Brolucizumab 6 mg
35
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Each Visit up to Week 100 for the Study EyeSecondary· 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
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 st
Week 4
Group
Value
95% CI
Brolucizumab 6 mg
5.1
4.3 – 6.0
Aflibercept 2 mg
4.2
3.4 – 5.1
Week 6
Group
Value
95% CI
Brolucizumab 6 mg
6.8
5.9 – 7.6
Aflibercept 2 mg
5.9
5.0 – 6.7
Week 8
Group
Value
95% CI
Brolucizumab 6 mg
7.8
6.9 – 8.7
Aflibercept 2 mg
6.7
5.8 – 7.5
Week 12
Group
Value
95% CI
Brolucizumab 6 mg
8.6
7.6 – 9.5
Aflibercept 2 mg
7.7
6.7 – 8.6
Week 16
Group
Value
95% CI
Brolucizumab 6 mg
9.0
7.9 – 10.1
Aflibercept 2 mg
8.3
7.2 – 9.5
Week 18
Group
Value
95% CI
Brolucizumab 6 mg
9.2
8.0 – 10.3
Aflibercept 2 mg
9.2
8.0 – 10.3
Week 20
Group
Value
95% CI
Brolucizumab 6 mg
9.6
8.4 – 10.8
Aflibercept 2 mg
9.4
8.2 – 10.6
Week 24
Group
Value
95% CI
Brolucizumab 6 mg
10.0
8.8 – 11.2
Aflibercept 2 mg
8.7
7.5 – 9.9
Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 4 to Week 52/100 for the Study EyeSecondary· Baseline, period Week 4 through Week 52, period Week 4 through Week 100
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 defin
period Week 4 through Week 52
Group
Value
95% CI
Brolucizumab 6 mg
9.1
8.2 – 10.1
Aflibercept 2 mg
8.4
7.4 – 9.3
period Week 4 through Week 100
Group
Value
95% CI
Brolucizumab 6 mg
9.8
8.8 – 10.9
Aflibercept 2 mg
8.7
7.7 – 9.8
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 EyeSecondary· 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
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 defin
period Week 20 through Week 52
Group
Value
95% CI
Brolucizumab 6 mg
10.1
8.9 – 11.2
Aflibercept 2 mg
9.3
8.1 – 10.4
period Week 20 through Week 100
Group
Value
95% CI
Brolucizumab 6 mg
10.4
9.2 – 11.7
Aflibercept 2 mg
9.2
8.0 – 10.4
period Week 28 through Week 52
Group
Value
95% CI
Brolucizumab 6 mg
10.1
9.0 – 11.3
Aflibercept 2 mg
9.4
8.2 – 10.5
period Week 28 through Week 100
Group
Value
95% CI
Brolucizumab 6 mg
10.5
9.3 – 11.7
Aflibercept 2 mg
9.2
8.0 – 10.5
Average Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Over the Period Week 88 to 100 for the Study EyeSecondary· Baseline, period Week 88 through Week 100
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 defin
Group
Value
95% CI
Brolucizumab 6 mg
10.8
9.2 – 12.3
Aflibercept 2 mg
8.7
7.1 – 10.2
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up to 30 days after last dose (maximum 35 months).
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05710471 — Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E
· Phase 4
· completed
NCT05266495 — Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting
· terminated
NCT04774926 — Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With
· Phase 4
· completed
NCT05657158 — Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retin
· completed
NCT04679935 — Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration
· Phase 4
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 7 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03481660.