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 range18 Years – 100 Years
SexALL
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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).
✕. 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.
What they're measuring
1
Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.