Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of patients with sight-threatening CNV in study eye
研究概览
简要总结
The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry AMD in study eye, Wet AMD in non-study eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Under 50;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
15 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
30 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/ML (Drug)
Anecortave Acetate Vehicle
Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Proportion of patients with sight-threatening CNV in study eye
时间窗: Month 48
次要结局
- Time to development of sight-threatening CNV(Up to 48 months)
- Proportion of patients with stable vision(Up to 48 months)