A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Mean change in intraocular pressure at 9 am from baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older with open-angle glaucoma.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Anecortave Acetate 3 mg Depot
Single injection, anterior juxtascleral depot (AJD)
干预措施: Anecortave Acetate Sterile Suspension, 6 mg/mL (Drug)
Anecortave Acetate 15 mg Depot
Single injection, anterior juxtascleral depot (AJD)
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
Anecortave Acetate 30 mg Depot
Single injection, anterior juxtascleral depot (AJD)
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/mL (Drug)
Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean change in intraocular pressure at 9 am from baseline
时间窗: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
次要结局
- Time to treatment failure(At time point)