CTRI/2023/06/054362尚未招募4 期
To compare effect of Inj ranibizumab0.25mg versus inj Aflibercept 1mg in Retinopathy of Prematurity.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Regression of ROP in-terms of change in percentage of vascularised retina
研究概览
简要总结
This study is a randomised, double blind, parallel group, single centre clinical trial comparing the efficacy of Intravitreal Inj Ranibizumab 0.25 mg versus Intravitreal Inj Aflibercept 1 mg in 124 eye, 62 prematurely newborn patients of Retinopathy of Prematurity that will be conducted at Army hospital Referral and Research, Delhi Cantt. in India. The primary outcome in terms of regression of ROP in terms of percentage of vascularised retina in 4 weeks. The secondary outcome will be measured in terms requirement of re Injection and time duration before re injection and recurrence after injection measured at 4 weeks and 8 weeks after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 28.00 Day(s) 至 90.00 Day(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Patients with stage 4 and stage 5 ROP Patients with pre existing ocular disease like congenital cataract, congenital glaucoma and other retinopathy.
结局指标
主要结局
Regression of ROP in-terms of change in percentage of vascularised retina
时间窗: 4 weeks
次要结局
- Requirement of re injection(Recurrence after injection)
研究者
研究点 (1)
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