NCT00065728终止3 期
An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Percent of patients who maintained stable vision
研究概览
简要总结
The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
- •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
Experimental
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
干预措施: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL (Drug)
结局指标
主要结局
Percent of patients who maintained stable vision
时间窗: Month 24
Stable vision is defined as \< 15-letter loss of best-corrected visual acuity scores)
Mean change in best-corrected visual acuity at Month 24 from baseline
时间窗: Baseline, Month 24
次要结局
未报告次要终点
研究者
研究点 (1)
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