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Sponsored by: |
Apheresis Research Institute |
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Information provided by: | Apheresis Research Institute |
ClinicalTrials.gov Identifier: | NCT00751361 |
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.
Condition | Intervention | Phase |
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Dry Age Related Macular Degeneration |
Device: Rheopheresis / double filtration plasmapheresis |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART |
Enrollment: | 52 |
Study Start Date: | November 1998 |
Study Completion Date: | January 2003 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks
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Device: Rheopheresis / double filtration plasmapheresis
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
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2: No Intervention
No treatment control group
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Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria for the treatment of Rheopheresis:
Germany | |
University of Frankfurt Department of Ophthalmology | |
Frankfurt, Germany, 60590 |
Principal Investigator: | Frank HJ Koch, Prof. Dr. | University of Frankfurt |
Responsible Party: | Apheresis Research Institute ( Reinhard Klingel, Prof. Dr. ) |
Study ID Numbers: | AR-2000 |
Study First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00751361 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Rheopheresis Dry Age Related Macular Degeneration AMD apheresis microcirculation |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |