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Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial (ART)

This study has been completed.
Sponsor:
Information provided by:
Apheresis Research Institute
ClinicalTrials.gov Identifier:
NCT00751361
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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
Dry Age Related Macular Degeneration
 Device: Rheopheresis / double filtration plasmapheresis
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Apheresis Research Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 weeks (7.5 months) ] [ Designated as safety issue: No ]

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
Active Comparator: 1
Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks
 Device: Rheopheresis / double filtration plasmapheresis
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
Other Names:
  • Rheopheresis
  • Double filtration plasmapheresis
No Intervention: 2
No treatment control group

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751361

Locations
Germany
University of Frankfurt Department of Ophthalmology
Frankfurt, Germany, 60590
Sponsors and Collaborators
Apheresis Research Institute
Investigators
Principal Investigator: Frank HJ Koch, Prof. Dr. University of Frankfurt
  More Information

No publications provided

Responsible Party: Reinhard Klingel, Prof. Dr., Apheresis Research Institute
ClinicalTrials.gov Identifier: NCT00751361     History of Changes
Other Study ID Numbers: AR-2000
Study First Received: September 10, 2008
Last Updated: September 10, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Apheresis Research Institute:
Rheopheresis
Dry Age Related Macular Degeneration
AMD
apheresis
microcirculation

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013