To observe the effectiveness of intravitreal bevacizumab biosimilar in retinal diseases
- Conditions
- Health Condition 1: H350- Background retinopathy and retinalvascular changesHealth Condition 2: H353- Degeneration of macula and posterior poleHealth Condition 3: H349- Unspecified retinal vascular occlusion
- Registration Number
- CTRI/2020/11/029268
- Lead Sponsor
- V Prasad Eye Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To assess the gain in visual acuity <br/ ><br>ERG changes before and after intravitreal injection <br/ ><br>To assess the reduction in central retinal thickness (CRT) <br/ ><br>Timepoint: 4, 8, 12, 16, 20 and 24 weeks