NCT00712491终止1 期
A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Santen Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Best-corrected visual acuity by ETDRS
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any other ocular disease that could compromise vision in the study eye
- •History of any prior treatment for choroidal neovascularization in the study eye
- •Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
研究组 & 干预措施
1
Experimental
干预措施: Sirolimus (Drug)
2
Experimental
干预措施: Sirolimus (Drug)
结局指标
主要结局
Best-corrected visual acuity by ETDRS
时间窗: 180 days
次要结局
- Best-corrected visual acuity by ETDRS(60 days, 120 days)
- Safety across injection routes(Through 1 year)
研究者
研究点 (1)
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