NCT00051129已完成3 期
An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 291
- 主要终点
- Mean change from baseline in logMAR visual acuity score at 12 months
研究概览
简要总结
The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).
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
- •Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Under 50 years.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Anecortave Acetate
Experimental
Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
干预措施: Anecortave Acetate 15 mg sterile suspension (Drug)
Anecortave Acetate Vehicle
Placebo Comparator
Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean change from baseline in logMAR visual acuity score at 12 months
时间窗: Month 12
次要结局
未报告次要终点
研究者
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