A Dose-Volume 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
- 终止
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure
研究概览
简要总结
The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes 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
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Prior angle surgery in the study eye, severe visual field loss in either eye;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
3 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Sterile Suspension, 6 mg/mL (Drug)
3 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Sterile Suspension, 3.75 mg/mL (Drug)
48 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Sterile Suspension, 96 mg/mL (Drug)
48 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/ML (Drug)
Anecortave Acetate Vehicle, low volume
Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Vehicle (Other)
Anecortave Acetate Vehicle, high volume
Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean Intraocular Pressure
时间窗: 6 months
次要结局
- Percent of patients who remain rescue-medication free(6 Months)