Clinical studies to implement Rheopheresis for age-related macular degeneration guided by evidence-based-medicine.

In the majority of age-related macular degeneration (AMD) patients the therapeutic situation is very unsatisfactory, especially for patients with dry AMD. Rheopheresis is a safe and effective modality of therapeutic apheresis to treat microcirculatory disorders, and represents a novel therapeutic approach for patients with dry AMD and soft drusen. Elimination of a defined spectrum of high molecular weight proteins from human plasma including pathophysiologically relevant risk factors for AMD such as fibrinogen, LDL-cholesterol, alpha 2-macroglobulin, fibronectin, and von-Willebrand factor results in the reduction of blood and plasma viscosity as well as erythrocyte and thrombocyte aggregation. Pulses of lowering blood and plasma viscosity performed as series of Rheopheresis treatments lead to rapid changes of blood flow, subsequently inducing sustained improvement of microcirculation, and recovery of retinal function. Two controlled randomized clinical trials demonstrated safety and efficacy of Rheopheresis for the treatment of AMD patients, especially with the dry form. Recently the interim-analysis of the sham-controlled, double blinded, randomized multicenter MIRA-I trial confirmed these results. The RheoNet-registry and the development and continuous update of therapy guidelines provide an appropriate framework for the quality management of the interdisciplinary cooperation between ophthalmologists with apheresis specialists. A hypothesis based upon current knowledge of pathogenic mechanisms of the development and progression of AMD can be conclusively linked with the putative mechanism of action of Rheopheresis for AMD. A recommendation for high-risk AMD-patients was defined. Based on the positive results of the MIRA-1 interim analysis eight Rheopheresis treatments are currently recommended as the initial treatment series.