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临床试验/NCT00150202
NCT00150202已完成3 期

Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Pfizer15 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年7月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
90
试验地点
15
主要终点
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.

研究概览

简要总结

This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Wet AMD, Visual Acuity from 20/320 to 20/40

排除标准

  • Diabetic retinopathy, laser coagulation history

结局指标

主要结局

Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.

次要结局

  • Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (15)

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