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Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema. - Trial NCT05959304

Access comprehensive clinical trial information for NCT05959304 through Pure Global AI's free database. This phase not specified trial is sponsored by Novartis Pharmaceuticals and is currently Not yet recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 66 participants.

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NCT05959304
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Trial Details
ClinicalTrials.gov โ€ข NCT05959304
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Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
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).

Study Focus

Diabetic Macular Edema

brolucizumab

Observational

other

Sponsor & Location

Novartis Pharmaceuticals

Novartis

Timeline & Enrollment

N/A

Dec 27, 2023

Jun 26, 2025

66 participants

Primary Outcome

Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.

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.

ICD-10 Classifications

Diabetic retinopathy
Other specified diabetes mellitus with ophthalmic complications
Unspecified diabetes mellitus with ophthalmic complications
Diabetic cataract
Type 2 diabetes mellitus with ophthalmic complications

Data Source

ClinicalTrials.gov

NCT05959304

Non-Device Trial