Health Condition 1: H350- Background retinopathy and retinalvascular changes Health Condition 2: H353- Degeneration of macula and posterior pole Health Condition 3: H349- Unspecified retinal vascular occlusion
Conditions
Interventions
Intervention1: Bevacizumab biosimilar (Zybev): Injections will be administered using standard sterile technique. The study eye will be prepped with 5% povidone-iodine solution �ushed copiously into
Sponsors
L V Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Center-involved macular edema or sub-retinal fluid or any subretinal hemorrhage secondary to diabetic macular edema, proliferative diabetic retinopathy, age related macular degeneration and retinal vein occlusion 2 .Adults more than/ equal to 18 years of age 3. ETDRS BCVA of 20/30 to 20/800 in the study eye 4. Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant during the full course of the study 5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures 6. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. History of vitreoretinal surgery in the study eye or anticipated within the next 12 months following Day 1 2. Previous treatment with anti-angiogenic drugs in the study eye or fellow eye in the past 3 months 3.Ocular inflammation (including trace or above) or external ocular inflammation in the study eye 4. History of idiopathic or autoimmune uveitis in either eye 5. Uncontrolled glaucoma, defined as IOP >= 25mmHg on optimal medical regimen, in either the study eye or fellow eye or previous filtration surgery in either the study eye or fellow eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of intravitreal injections of 1.25 mg biosimilar bevacizumab (Zybev, Zydus Cadila, Ahmedabad, India) in various retinal diseasesTimepoint: 4, 8, 12, 16, 20, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the gain in visual acuity ERG changes before and after intravitreal injection To assess the reduction in central retinal thickness (CRT) Timepoint: 4, 8, 12, 16, 20 and 24 weeks | — |
Countries
India
Contacts
Public ContactDrRaja Narayanan
LV Prasad Eye Institute
Outcome results
None listed