A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure at 8 am
研究概览
简要总结
The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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
- Triple (Participant, Care Provider, 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 (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patients with any form of glaucoma other than open-angle.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
24 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
48 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/mL (Drug)
60 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
干预措施: Anecortave Acetate Sterile Suspension, 75 mg/mL (Drug)
Anecortave Acetate Vehicle
Single depot administration of 0.8 mL in the study eye
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean Intraocular Pressure at 8 am
时间窗: Up to 6 months
次要结局
- Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)(Month 3, 8 am)