Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
研究概览
简要总结
The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with 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
- •Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Less than 50 years of age.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
15 mg Anecortave Acetate, 3 month intervals
Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months).
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
15 mg Anecortave Acetate, 6 month intervals
Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
干预措施: Anecortave Acetate Sterile Suspension, 30 mg/mL (Drug)
30 mg Anecortave Acetate, 6 month intervals
Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/mL (Drug)
Anecortave Acetate Vehicle
One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
时间窗: Month 12
次要结局
- Mean change in lesion growth at Month 12 from baseline(Month 12)