drugset / Trial / NCT03481660
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
RandomizedParallel-groupDouble-blindTreatment
Summary
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).
Timeline
- Start
- 2018-07-27
- Primary completion
- 2020-06-29
- Completion
- 2021-06-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Brolucizumab | Other / unclassified | 6 mg | Intravitreal |