Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT04079231
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
- Diabetic Macula Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 110 Years
- Healthy Volunteers
- Not accepted
Interventions
- Brolucizumab — DRUGIntravitreal Injection
- Aflibercept — DRUGIntravitreal injection
Study Details
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Key Dates
- Start date
- Feb 1, 2021
- Status verified
- Jan 2021
- Primary completion
- Jan 31, 2023
- Completion
- Jan 31, 2023
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Brolucizumab 6 mgBrolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
- Active Comparator: Aflibercept 2 mgAflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Primary Outcome Measure
Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48 [ Time Frame: Week 48 ]