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Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
Sponsor: Novartis Pharmaceuticals
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
Conditions
Interventions
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