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Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00078221
Recruitment Status : Unknown
Verified December 2005 by OccuLogix.
Recruitment status was:  Active, not recruiting
First Posted : March 1, 2004
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.

Condition or disease Intervention/treatment Phase
Macular Degeneration Device: Rheopheresis blood filtration Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1999
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Age 50-85
  • Diagnosis of Dry AMD
  • BCVA between 20/32 and 20/125 in at least one eye
  • Numerous large plaques (soft drusen)
  • No history of HIV, Hepatitis B or C
  • Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA
Contacts and Locations

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): NCT00078221


Locations
United States, California
Retina Vitreous Associates
Beverly Hills, California, United States, 90211
United States, Florida
Aran Eye Associates
Coral Gables, Florida, United States, 33134
Retina Health Care
Ft. Myers, Florida, United States, 33901
United States, Illinois
UIC Eye Center
Chicago, Illinois, United States, 60612
United States, New York
Macula Care
New York, New York, United States, 10021
United States, North Carolina
Carolina Eye Associates
Southern Pines, North Carolina, United States, 28387
United States, Pennsylvania
Associated Retinal Consultants
Bala Cynwyd, Pennsylvania, United States, 19004
Canada, Ontario
W. Bradley Kates, MD
Oakville,, Ontario, Canada, L6H 3P1
Sponsors and Collaborators
OccuLogix
Investigators
Study Director: Irving Siegel, MD OccuLogix
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00078221     History of Changes
Other Study ID Numbers: AMD-02-99
First Posted: March 1, 2004    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: December 2005

Keywords provided by OccuLogix:
Dry AMD
Age-related Macular Degeneration
Rheopheresis

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