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NCT05959304

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).
Novartis Pharmaceuticals·ClinicalTrials.gov·otherNot yet recruiting
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Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
brolucizumab
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Novartis Pharmaceuticals
Funder
Novartis
Timeline & enrollment
Phase
N/A
Start date
Dec 27, 2023
End date
Jun 26, 2025
Enrollment
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 retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05959304
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.