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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014