Abstract
Abstract: :
Purpose: Rheopheresis is an apheresis therapy system designed to treat microcirculatory disorders. 3 randomized clinical trials demonstrated that 8 to 10 Rheopheresis treatments over 10–21 weeks promote sustained improvement of the natural course of AMD. The multicenter, double masked placebo controlled MIRA–1–trial is in its final phase to evaluate efficacy of Rheopheresis for dry AMD with soft drusen. Rheopheresis has been approved by medical device regulations in Europe and Canada, and there is available for high–risk AMD patients without an alternative therapeutic option. RheoNet–registry was established for interdisciplinary quality management of Rheopheresis. Methods: RheoNet is regularly analysed for safety aspects of Rheopheresis. Efficacy for AMD can be evaluated with data provided by ophthalmologists responsible for indication and follow–up examination. Registry analysis reference controlled by results of clinical trials represents a direct transfer of evidence–based medicine into clinical practice. Results: In Nov. 2004, 4096 Rheopheresis treatments of 678 pts., including 439 pts. with AMD, 164 pts. with sudden deafness/tinnitus, 9 with ischemic diabetic foot syndrome, and 12 with critical limb ischemia were recorded. Mean age of treated pts. was 66 yrs. (AMD 74 yrs.). In 5.35% (all)/ 5.41% (AMD) of treatments adverse events (AE) were reported, but only in 1.84% (all)/ 0.51% (AMD) were followed by discontinuation of the treatment. 26.4 % of AMD pts. were 80 yrs. or older, but did not exhibit increased incidence of AEs. With 2.27% (all)/ 2.23% (AMD) transient hypotension was the most frequently reported AE. Vascular access problems were reported in 6.91% (all)/ 6.54% (AMD) of treatments, but only in 1.00% (all)/0.86% (AMD) did'nt allow complete treatment. Ophthalmological data of 165 eyes of 118 AMD pts. could be analyzed for this registry analysis including 149 eyes (108 pts.) with dry AMD, VA >0.1 and 16 eyes (10 pts.) with pigment epithelial detachment (PED). Patients received in mean 8.7 Rheopheresis treatments. For eyes with dry AMD, mean change in ETDRS–VA after Rheopheresis compared to baseline was +0.9 lines. For the group with PED, ETDRS–line change was +0.3. Conclusions: Rheopheresis can be regarded as a safe ambulatory treatment for elderly patients with AMD. Current RheoNet analysis showed results which were in good accord with study data.
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • lipids