NCT00942864已完成3 期
An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
研究概览
简要总结
The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
- •Male and female aged from 18 to 70
- •Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart
排除标准
- •Additional eye disease that could compromise VA
- •Ocular inflammation
- •Intraocular surgery ≤ 1 month before day 0
- •Uncontrolled glaucoma
- •Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
- •Patients aged under 18 or over 71
- •Female patient in pregnancy or breast feeding
- •Not suitable to regular follow up
结局指标
主要结局
The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
时间窗: every 4 weeks (up to 52 weeks)
次要结局
- The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).(every 4 weeks (up to 52 weeks))
研究者
研究点 (2)
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