A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oculis
- 入组人数
- 552
- 试验地点
- 97
- 主要终点
- Mean Change 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 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema
Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.
Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
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) - Stage 1:
- •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 central subfield thickness (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 at Visit 1 (Screening).
- •Inclusion Criteria (selection) - Stage 2:
- •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 central subfield thickness (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 Visit 1 (Screening).
排除标准
- •(selection) - Stage 1 and Stage 2:
- •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
dexamethasone ophthalmic suspension,1.5% [15 mg/ mL]
干预措施: Dexamethasone ophthalmic suspension (OCS-01) (Drug)
Vehicle Vehicle
Placebo is a Vehicle ophthalmic suspension of OCS-01
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean Change 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
- Mean Change in BCVA(Baseline, Week 12 and Week 24)
- Percentage of Participants with a 3-line or Greater Gain in BCVA(Baseline, Week 52)
- Mean Change in Central Subfield Thickness (CST)(Baseline, Week 52)