A Prospective, Randomized, Double-masked, Controlled Study on Intravitreal Bevacizumab (Avastin) Versus Verteporfin (Visudyne) Photodynamic Therapy (PDT) for Patients With Neovascular Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
研究概览
简要总结
The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.
详细描述
Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.
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
- 否
入选标准
- •patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions
- •visual acuity >=0.1
排除标准
- •patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions
- •subfoveal hemorrhage (>1DA) or fibrosis
- •patients previously treated for neovascular AMD in the study eye
研究组 & 干预措施
Avastin
干预措施: Bevacizumab (Avastin) (Drug)
Avastin
干预措施: Verteporfin photodynamic therapy (PDT) (Drug)
Visudyne
干预措施: Bevacizumab (Avastin) (Drug)
Visudyne
干预措施: Verteporfin photodynamic therapy (PDT) (Drug)
结局指标
主要结局
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
时间窗: 1 year
次要结局
- Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.(1 year)
- Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.(1 year)
研究者
Anders Kvanta
Professor
St. Erik Eye Hospital
