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ACTIVE NOT RECRUITING
NCT05959304
PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2024-12-11

Completion Date

2026-02-28

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DRUG

brolucizumab

There is no treatment allocation. Treatment with brolucizumab 6 mg intravitreal injection will be based on the local label/clinical practice.

Locations (8)

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Bangalore, Karnataka, India

Novartis Investigative Site

Kochi, Kerala, India

Novartis Investigative Site

Chennai, Tamil Nadu, India

Novartis Investigative Site

Kolkata, West Bengal, India

Novartis Investigative Site

Coimbatore, India

Novartis Investigative Site

Kolkata, India

Novartis Investigative Site

New Delhi, India