NCT02072408已完成4 期
Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Change of best-corrected visual acuity (ETDRS letters)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •polypoidal choroidal vasculopathy without active polyp
- •decreased visual acuity by subretinal fluid and hemorrhage involving foveal center
排除标准
- •polypoidal choroidal vasculopathy with active polyp
- •previous photodynamic therapy more than three times
- •anti-VEGF injection within one month
- •photodynamic therapy or intraocular steroid treatment within three months
研究组 & 干预措施
polypoidal choroidal vasculopathy without polyp
Experimental
干预措施: aflibercept (Drug)
结局指标
主要结局
Change of best-corrected visual acuity (ETDRS letters)
时间窗: 1 year
次要结局
- safety outcomes(one year)
- presence of subretinal hemorrhage(during 1 year)
- change of indocyanine green angiography(during 1 year)
- Number of eyes which need rescue treatment (photodynamic therapy)(during 1 year)
- presence of fluid in macula evidenced by optical coherence tomography(during 1 year)
研究者
研究点 (3)
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