A clinical trial to compare effect of Injection Ranibizumab 0.25 mg versus Injection Aflibercept 1mg in infants of Retinopathy of Prematurity.
Phase 4
- Conditions
- Health Condition 1: H351- Retinopathy of prematurity
- Registration Number
- CTRI/2023/06/054362
- Lead Sponsor
- Army Hospital Referral and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Premature newborns of APROP (aggressive posterior rop) and Hybrid ROP which is presence of ridge tissue, characteristic of staged ROP along with flat neovascular syncytium, and character of APROP in same eye.
Exclusion Criteria
Patients with stage 4 and stage 5 ROP
Patients with pre existing ocular disease like congenital cataract, congenital glaucoma and other retinopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Regression of ROP in-terms of change in percentage of vascularised retinaTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Requirement of re injection <br/ ><br>Recurrence after injection <br/ ><br>Time duration before re injectionTimepoint: 4 weeks