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临床试验/NCT00134667
NCT00134667终止4 期

A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Eyetech Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2005年3月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
360
试验地点
2

研究概览

简要总结

The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

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

  • Subjects of either gender; aged 50 years or greater.
  • Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition
  • Best corrected visual acuity in the study eye between 20/40 and 20/200

排除标准

  • Any prior PDT with Visudyne to the study eye
  • Any previous AMD thermal laser therapy to the study eye

研究者

申办方类型
Industry

研究点 (2)

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