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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks |
|
| 2 | No Intervention | No treatment control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rheopheresis / double filtration plasmapheresis | Device | Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. | 30 weeks (7.5 months) |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria for the treatment of Rheopheresis:
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| Name | Affiliation | Role |
|---|---|---|
| Frank HJ Koch, Prof. Dr. | University of Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Frankfurt Department of Ophthalmology | Frankfurt | 60590 | Germany |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| D013514 | Surgical Procedures, Operative |