Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Di… (NCT05959304) | Clinical Trial Compass
CompletedPhase 4
Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
India66 participantsStarted 2024-12-11
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.
. Patient with existing or suspected ocular or periocular infection in the study eye.
. Patient with an existing intraocular inflammation (IOI) in the study eye.
. 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 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.
. Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.