CTRI/2024/07/071429尚未招募3 期
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema. - (DIAMOND-2)
Oculis Operations Sàrl0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Have a signed informed consent form before any study-specific procedures are performed.
- •2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of =310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
- •3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of = 10.0% prior to screening (Visit 1).
排除标准
- •1. Have macular edema considered to be because of a cause other than DME.
- •2. Have a decrease in BCVA because of causes other than DME.
- •3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
研究者
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