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临床试验/NCT00383812
NCT00383812Unknown不适用

Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Asan Medical Center2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2006年5月最近更新:
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适应症
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.
研究概览研究设计入排标准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

  1. Primary objectives

a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV) 2. Secondary objectives

  1. To assess the changes in visual acuity
  2. To assess the change in lesion characteristics of PCV
  • size of PCV
  • fluorescein leakage
  • foveal thickness
  1. To investigate the safety of intravitreal Bevacizumab in patients with PCV
  2. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female, CNV secondary to PCV
  • •BCVA of 20/40 to 20/320 (Snellen equivalent)
  • •Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)

排除标准

  • •Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity
  • •Media opacity in the study eye that precludes clinical and photographic evaluation
  • •Intraocular surgery < 1 month before day 0
  • •Use of heparin/warfarin within 1 month prior to injection
  • •Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine
  • •Contraindication to pupil dilation in either eye
  • •Any condition which precludes patients' ability to comply with study requirements including completion of the study

结局指标

主要结局

To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.

To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse

次要结局

  • To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT)
  • To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA)

研究者

申办方类型
Other

研究点 (2)

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