drugset / Trial / NCT03481660

A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT03481660

Phase 3 Completed 360 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject Brolucizumab Other / unclassified 6 mg Intravitreal