NCT00401115已完成1 期
A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 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
- 1 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy
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
- None
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
Subconjunctival injection
干预措施: MS-R001 (rapamycin) (Drug)
2
Experimental
Intraocular injection
干预措施: MS-R001 (rapamycin) (Drug)
结局指标
主要结局
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
时间窗: 12 months
次要结局
- Visual Acuity(90 days)
研究者
研究点 (2)
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