Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration — ReLux-AMD  

Age-related Macular Degeneration Clinical Trial

Official title: Rheohemapheresis and Lutein Supplementation (Xantophyll Carotenoid) in the Non-Exsudative Form of Age-Related Macular Degeneration

Status Active, not recruiting

Clinical Trial Summary

Age-related macular degeneration is one of the major causes of blindness in the western world. There is an exsudative and a non-exsudative form of age-related macular degeneration.Most studies concentrate on the exsudative form. In the non-exsudative form the policy is generally watch and see, but patients are at risk to develop an exsudative form. So far, the only accepted therapy to reach stable disease in the non-exsudative form is high-dose supplementation of antioxidants. Another approach to improve visual acuity in patients with non-exsudative form of macular degeneration is rheohemapheresis treatment, an extracorporeal therapy where plasma is separated from blood cells. By the use of a hollow fiber filter plasma is depleted of high molecular weight proteins and reinfused. Others report describe the supplementation of lutein (a vitamin A derivative) as possible treatment option. However, none of the studies have yet examined a combination of rheohemapheresis and lutein supplementation.

Clinical Trial Description

Rheohemapheresis will be performed in 5 cycles. One cycle consists of 2 rheohemapheresis treatments on day 1 and day 4. A cycle lasts for 4 weeks and will be repeated every fourth week. During each treatment > 75% to 100% of patients total plasma volume has to be filtered.General medical reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with OCT 3, autofluorescein imaging and infrared imaging, multifocal ERG, ocular echography, and blood examinations will be performed. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

• NCT number: NCT00443911
• Study type: Observational
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2007
• Completion date: May 2012