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.
Oculis Operations SÃ rl7 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年8月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 7
- 主要终点
- Mean change from baseline in BCVA (Best Corrected Visual Acuity)- Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity
研究概览
简要总结
This is randomized, placebo controlled, parallel-group, phase 3 study to enroll approx. 32 subjects from India [Male or Female of 18 to 85 years of age with type 1 or 2 diabetes mellitus and diabetic macular edema (DME)].
The objective of this study is to demonstrate efficacy and safety of OCS-01 as compared to vehicle/placebo at Week 52. OCS-01 is a novel topical eye drop formulation with a different route of administration from the currently available therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a signed informed consent form before any study-specific procedures are performed.
- •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).
- •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
- •Have macular edema considered to be because of a cause other than DME.
- •Have a decrease in BCVA because of causes other than DME.
- •Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
结局指标
主要结局
Mean change from baseline in BCVA (Best Corrected Visual Acuity)- Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity
时间窗: Week 52
次要结局
- Proportion of subjects with 3-line or greater gain in BCVA ETDRS letters compared with baseline(Week 52)
研究者
研究点 (7)
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