NCT00656643已完成2 期
A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 131
- 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 at various doses in patients with diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Sirolimus (Drug)
2
Experimental
干预措施: Sirolimus (Drug)
3
Experimental
干预措施: Sirolimus (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Best-corrected visual acuity by ETDRS
时间窗: 180 days
次要结局
- Foveal central subfield thickness as determined by OCT(180 days)
- Safety across dose groups versus placebo(180 days)
研究者
研究点 (1)
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