NCT06172257进行中（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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Oculis
- 入组人数
- 401
- 试验地点
- 116
- 主要终点
- Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
详细描述
A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(selection):
- •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 prior to screening (Visit 1).
排除标准
- •(selection):
- •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.
研究组 & 干预措施
OCS-01
Experimental
dexamethasone ophthalmic suspension,1.5% [15 mg/mL]
干预措施: Dexamethasone ophthalmic suspension (OCS-01) (Drug)
Vehicle ophthalmic suspension
Placebo Comparator
Vehicle of OCS-01
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)
时间窗: Week 52
Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.
次要结局
- Percentage of Participants With a 3-line or Greater Gain in BCVA(Baseline, Week 52)
- Mean Change in BCVA(Baseline, Week 12 and Week 24)
- Mean Change in Central Subfield Thickness (CST)(Baseline, Week 52)
研究者
研究点 (116)
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