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临床试验/NCT00347399
NCT00347399终止2 期

Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy

Asociación para Evitar la Ceguera en México2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年3月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
25
试验地点
2
主要终点
Visual acuity improvement at 6 months

研究概览

简要总结

The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

详细描述

The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

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
55 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR)

排除标准

  • Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

结局指标

主要结局

Visual acuity improvement at 6 months

时间窗: undefined

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次要结局

  • Retinal thickness improvement at 6 months(undefined)

研究者

发起方
Asociación para Evitar la Ceguera en México
申办方类型
Other
责任方
Sponsor

研究点 (2)

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