NCT00751361已完成4 期
Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART
Apheresis Research Institute2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 1998年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.
研究概览
简要总结
Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.
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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 85 years old
- •diagnosis of AMD in both eyes
- •must have dry AMD in the study eye
- •Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
- •peripheral veins allowing vascular access to establish the extracorporal circuit.
排除标准
- •other retinal or choroidal disorders than AMD
- •optic nerve disease, glaucoma
- •conditions that limit the view of the fundus
- •acute bleeding in any eye
- •General exclusion criteria for the treatment of Rheopheresis:
- •haemorrhagic diathesis or coagulopathy
- •serious acute or chronic kidney or liver failure
- •hypotension systolic < 100 mmHg
- •chronic viral infection (HIV, hepatitis B, C)
- •epilepsia, psychosis or dementia
- •a malignant disease or any other condition with life expectancy < 12 months
- •known history of alcohol or drug abuse and long term serious nicotine abuse
结局指标
主要结局
The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.
时间窗: 30 weeks (7.5 months)
次要结局
未报告次要终点
研究者
研究点 (2)
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