NCT05959304CompletedPhase 4
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).
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 17 Jul 2023
- Start date
- Dec 2024
- Primary completion date
- Nov 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Diabetic eye disease
- NCT number
- NCT05959304
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 66
- From Dec 2024 to the primary completion date, Nov 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant conditions or ocular disorders in the study eye at screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
- Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
- Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
- Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.
- Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye.
Other illness
- Patient with existing or suspected ocular or periocular infection in the study eye.
Other
- Patient with an existing intraocular inflammation (IOI) in the study eye.
- Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye.
- Active proliferative diabetic retinopathy in the study eye as per Investigator.
- Pregnant or nursing (lactating) women at screening, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG pregnancy test.
Who the study is looking for
- Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
- Patients with type 1 or type 2 diabetes mellitus.
- Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.
- \-
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| - Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| - Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| - Coordinator of this site? Confirm its status | Kochi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| - Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.