Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE
详细描述
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute BRVO with less than three month duration
排除标准
- •vision less than 20/320 and vison more than 20/50
- •duration more than 3 months
- •history of glaucoma and diabetic retinopathy
- •any media opacity that prevent funduscopy
研究组 & 干预措施
1
Intravitreal injection of Avastin
干预措施: Avastin (Bevacizumab) (Drug)
2
干预措施: Avastin (Bevacizumab) (Drug)
结局指标
主要结局
Best corrected visual acuity
时间窗: At 12 week
Macular thickness by OCT
时间窗: At 12 week
次要结局
- Need for macular photocuagulation(At 12th week)
- Incidence of new vessel formation(At 12th week)