Anecortave Acetate Risk-Reduction Trial (AART)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,596
- 试验地点
- 1
- 主要终点
- Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48
研究概览
简要总结
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry AMD 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
AL-3789
One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.
干预措施: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg (Drug)
Anecortave Acetate Vehicle
One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was 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 (ST-CNV) in the study eye at Month 48
时间窗: Month 48
ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.
次要结局
未报告次要终点