NCT00315640已完成2 期
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Mean change in IOP at Week 4 from Baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender
- •18 years of age or older
- •IOP elevation caused by steroid usage
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Under 18 years of age
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Anecortave Acetate 3 mg Depot
Experimental
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
干预措施: Anecortave Acetate Sterile Suspension, 6 mg/mL (Drug)
Anecortave Acetate 15 mg Depot
Experimental
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
干预措施: Anecortave Acetate Suspension Depot, 30 mg/mL (Drug)
Anecortave Acetate 30 mg Depot
Experimental
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
干预措施: Anecortave Acetate Sterile Suspension, 60 mg/mL (Drug)
Anecortave Acetate Vehicle
Other
干预措施: Anecortave Acetate Vehicle (Other)
结局指标
主要结局
Mean change in IOP at Week 4 from Baseline
时间窗: Week 4
次要结局
未报告次要终点
研究者
研究点 (11)
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