Phase 3
Completed N=566
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Source: ClinicalTrials.gov NCT03481634 ↗Enrolled (actual)
566
Serious AEs
31.8%
Results posted
Oct 2022
Primary outcomePrimary: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 — 7.3; 10.6; 9.2; 10.5 Scores on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 |
7.3; 10.6; 9.2; 10.5 | <0.001 sig |
| SECONDARY Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 |
7.0; 10.5; 9.0; 10.5 | <0.001 sig |
| SECONDARY Patients Maintained at q12w - Probability of Maintaining on q12w |
1; 1; 0.758; 0.807; 0.545; 0.628 | — |
| SECONDARY Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w |
1; 1; 0.870; 0.876 | — |
| SECONDARY Change From Baseline in BCVA at Each Visit up to Week 52 |
4.0; 4.5; 5.1; 5.1; 6.0; 6.8 | — |
| SECONDARY BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) |
6.7; 10.6; 8.6; 10.6 | — |
| SECONDARY Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w |
1; 1; 0.758; 0.807; 0.545; 0.628 | — |
| SECONDARY Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results |
-104.7; -104.1; -105.6; -103.4; -107.1; -119.3 | — |
| SECONDARY Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) |
-167.1; -168.8; -171.9; -168.5 | — |
| SECONDARY Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit |
26; 23; 27; 20; 17; 17 | — |
| SECONDARY Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit |
176; 169; 169; 177; 169; 169 | — |
| SECONDARY Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit |
177; 172; 171; 177; 173; 169 | — |
| SECONDARY Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 |
114; 108; 140 | — |
| SECONDARY Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 |
94; 80; 104 | — |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects |
44; 49; 39; 53; 55; 40 | — |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates |
23.3; 21.7; 25.8; 21.7; 28.0; 22.3 | — |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects |
23; 32; 22; 24; 39; 30 | — |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates |
12.1; 12.3; 16.8; 12.2; 12.6; 16.8 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score |
5.5; 6.0; 7.8; 4.6; 6.7; 8.5 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision |
7.8; 10.8; 11.3; 6.6; 11.2; 10.7 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain |
2.2; 2.4; 4.3; 1.0; 4.9; 5.3 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities |
8.4; 13.2; 13.7; 8.1; 14.1; 13.4 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities |
6.0; 7.9; 9.0; 4.2; 9.0; 9.9 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning |
2.7; 2.2; 3.9; 3.1; 2.7; 3.8 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health |
7.8; 8.2; 8.7; 7.9; 9.6; 11.3 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties |
8.0; 6.5; 9.4; 6.9; 6.1; 11.3 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency |
6.3; 6.1; 7.1; 3.8; 4.1; 9.0 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving |
4.7; 1.9; 6.7; 5.2; 3.6; 6.4 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision |
2.6; 2.6; 1.8; 2.0; 2.0; 1.6 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision |
3.6; 1.6; 9.2; 1.3; 4.1; 8.5 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating |
0.9; 3.0; 6.1; 4.3; 6.8; 6.8 | — |
| SECONDARY Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye |
103; 92; 94; 17; 16; 13 | — |
| SECONDARY Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) |
146; 146; 143 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent before any assessment
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
- Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion Criteria
- Active proliferative diabetic retinopathy in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in study eye
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
Other protocol-specified inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03481634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.