Anecortave Acetate Risk Reduction Trial (AART)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye
研究概览
简要总结
The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.
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 non-study eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Anecortave Acetate, 15 mg
One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
Anecortave Acetate, 30 mg
One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/mL (Drug)
Anecortave Acetate Vehicle
One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye
时间窗: Month 48
次要结局
- Time to development of sight-threatening CNV(Timepoint)