Rationalization of the Systemic Treatment of Age-related Macular Degeneration With Rheohemapheresis (RHF)
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Electroretinography
研究概览
简要总结
In this research rheohemapheresis will be used for the treatment of patients with high-risk dry form of age-related macular degeneration. Correction of rheologic parameters and activation of retinal functional reserves after the therapy will positively influence functional condition of retina. The newest special electrophysiologic methods will be used to determine retinal changes in time. The investigators will also evaluate some important immunologic factors and complement changes as well as define indication criteria more precisely.
详细描述
With optimized therapeutic protocol we would prevent progression of the dry form of AMD into its devastating wet form and stabilize the situation. We suppose that retinal morphologic and functional conditions would improve in a high percentage of patients. Also possible technical and economic savings would not be less important with our own therapeutic protocol, especially, when blindness could be prevented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AMD in the stage of soft drusen, grade 1-3 according to European Eye Study (EURYEYE) (see reference No 1), body weight over 50 Kilo and with other feasible indications for aphereses therapy (peripheral veins allowing vascular access to establish the extracorporal circuit).
排除标准
- •Study eye with exudative AMD
- •Study eye with concomitant retinal or choroidal disorder other than AMD
- •Study eye with significant central lens opacities and/or conditions that limit the view of the fundus
- •uncontrolled diabetes, uncontrolled arterial hypertension
- •insufficient antecubital venous access
- •haemato-oncological malignancies
- •patients who are unwilling to adhere to visit examination schedules . poor general condition (serious diseases - infections,cardiovascular or cerebral insufficience, severe IHD)
研究组 & 干预措施
Rheohemapheresis
Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. Best-corrected visual acuity, electroretinography and drusenoid retinal pigment epithelium detachment area will be examined. Changes of selected special immunologic parameters will be measured.
干预措施: rheohemapheresis (Procedure)
without rheohemapheresis
Into the group the patients will be randomized with the same disease but without rheohemapheresis
结局指标
主要结局
Electroretinography
时间窗: 2.5 years
Evaluation of functional changes in single retinal layers and areas by newest special electrophysiologic methods
次要结局
- immunologic parameters changes(2.5 years)
研究者
Karel Antos
Deputy director
University Hospital Hradec Kralove