drugset / Trial / NCT05959304

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

NCT05959304

Phase 4 Completed 66 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.

Timeline

Start
2024-12-11
Primary completion
2025-11-17
Completion
2025-11-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Brolucizumab Other / unclassified 6 mg Intravitreal