Health Condition 1: E103- Type 1 diabetes mellitus with ophthalmic complications Health Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Intravitreal injections (IVI) of Brolucizumab: A prospective, multi-center, open-label, phase IV study to evaluate the safety and effectiveness of intravitreal injections (IVI) of Brolu
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet all of the following 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) willing to voluntarily provide signed informed consent for participation in the study. Note: In the case where both eyes are affected by DME, data of only one eye [referred to as â??study eye ?] will be recorded in which brolucizumab is administered. Selection of the study eye will be as per the Investigatorâ??s discretion.
Exclusion criteria
Exclusion criteria: Patients with any of the following criteria are not eligible for this study: 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 greater than 25 mmHg despite treatment with anti glaucoma medication, or according to Investigatorâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with brolucizumab.Timepoint: 40 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the mean change in BCVA from Baseline to Week 40 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. 2. To describe the proportion of patients with presence/absence of IRF and SRF at Week 40 compared to Baseline. 3. To describe mean change in CRT as assessed by Optical Coherence Tomography (OCT) from Baseline to Week 40. 4. To describe the number of brolucizumab injections administered to the patients, number of non-injection visits, and total number of visits during 40 weeks of treatment with brolucizumab.Timepoint: 40 weeks | — |
Countries
India
Contacts
Public ContactDr Anup Thorat
Novartis Healthcare Private Limited
Outcome results
None listed