Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
ART
Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART
1 other identifier
interventional
52
1 country
1
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 using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 1998
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 10, 2008
CompletedFirst Posted
Study publicly available on registry
September 11, 2008
CompletedSeptember 11, 2008
September 1, 2008
4.2 years
September 10, 2008
September 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
1
ACTIVE COMPARATORTreatment group: Patients receive 10 Rheopheresis treatments within 17 weeks
2
NO INTERVENTIONNo treatment control group
Interventions
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- other retinal or choroidal disorders than AMD
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Frankfurt Department of Ophthalmology
Frankfurt, 60590, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank HJ Koch, Prof. Dr.
University of Frankfurt
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 10, 2008
First Posted
September 11, 2008
Study Start
November 1, 1998
Primary Completion
January 1, 2003
Study Completion
January 1, 2003
Last Updated
September 11, 2008
Record last verified: 2008-09