Status:
COMPLETED
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
Lead Sponsor:
Apheresis Research Institute
Conditions:
Dry Age Related Macular Degeneration
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00751361
Start Date
November 1 1998
End Date
January 1 2003
Last Update
September 11 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Frankfurt Department of Ophthalmology
Frankfurt, Germany, 60590