临床试验/NCT00138632

NCT00138632已完成1 期

A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Novartis9 个研究点分布在 2 个国家目标入组 50 人开始时间: 2005年9月最近更新: 2008年11月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novartis
入组人数: 50
试验地点: 9
主要终点: Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema.

In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 65 Years 至 —（Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

3

Placebo Comparator

干预措施: Placebo (Drug)

1

Experimental

干预措施: PTK787 (Drug)

2

Experimental

干预措施: PTK787 (Drug)

结局指标

主要结局

Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months

时间窗: up to 12 months

次要结局

Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3(from baseline up to 3 months)

研究者

发起方

Novartis

申办方类型

Industry

研究点 (9)

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