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

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ClinicalTrials.gov Identifier: NCT00751361
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : September 11, 2008
Sponsor:
Information provided by:
Apheresis Research Institute

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.

Condition or disease Intervention/treatment Phase
Dry Age Related Macular Degeneration Device: Rheopheresis / double filtration plasmapheresis Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 1998
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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. [ Time Frame: 30 weeks (7.5 months) ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Reinhard Klingel, Prof. Dr., Apheresis Research Institute
ClinicalTrials.gov Identifier: NCT00751361     History of Changes
Other Study ID Numbers: AR-2000
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: September 11, 2008
Last Verified: September 2008

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