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

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Diabetic Macular Edema

Interventions: brolucizumab

Countries: India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
2. Patients with type 1 or type 2 diabetes mellitus.
3. Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.

Exclusion Criteria:

1. 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).
2. Patient with existing or suspected ocular or periocular infection in the study eye.
3. Patient with an existing intraocular inflammation (IOI) in the study eye.
4. Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
5. Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
6. Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye.
7. Active proliferative diabetic retinopathy in the study eye as per Investigator.
8. Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.
9. Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye.
10. 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.

Locations (8)

Ahmedabad, Gujarat, India
Bangalore, Karnataka, India
Kochi, Kerala, India
Chennai, Tamil Nadu, India
Kolkata, West Bengal, India
Coimbatore, India
Kolkata, India
New Delhi, India