Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial

Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

• anaemia
• haemorrhagic diathesis or coagulopathy
• diabetes
• 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