NCT00906685已完成3 期
A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Anders Kvanta1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of patients gaining 15 ETDRS letters or more
研究概览
简要总结
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRVO with duration < 6 months
- •Visual acuity of 20/800 to 20/50
排除标准
- •CRVO with duration of > 6 months
- •previous treatment with anti-angiogenic drugs
研究组 & 干预措施
Intravitreal bevacizumab
Active Comparator
干预措施: bevacizumab (Drug)
Sham injection
Sham Comparator
干预措施: Sham bevacizumab injection (Drug)
结局指标
主要结局
The proportion of patients gaining 15 ETDRS letters or more
时间窗: 6 months
次要结局
- Change in foveal thickness(6 months)
- Cases of neovascular glaucoma(6 months)
研究者
Anders Kvanta
Professor
St. Erik Eye Hospital
研究点 (1)
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