Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
NCT ID: NCT00751361
Last Updated: 2008-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
1998-11-30
2003-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks
Rheopheresis / double filtration plasmapheresis
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
2
No treatment control group
No interventions assigned to this group
Interventions
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Rheopheresis / double filtration plasmapheresis
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* optic nerve disease, glaucoma
* conditions that limit the view of the fundus
* acute bleeding in any eye
* 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
50 Years
85 Years
ALL
No
Sponsors
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Apheresis Research Institute
OTHER
Responsible Party
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Apheresis Research Institute
Principal Investigators
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Frank HJ Koch, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Frankfurt
Locations
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University of Frankfurt Department of Ophthalmology
Frankfurt, , Germany
Countries
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Other Identifiers
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AR-2000
Identifier Type: -
Identifier Source: org_study_id