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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by OccuLogix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
OccuLogix
ClinicalTrials.gov Identifier:
NCT00078221
First received: February 20, 2004
Last updated: May 8, 2008
Last verified: December 2005
  Purpose

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 Intervention Phase
Macular Degeneration
Device: Rheopheresis blood filtration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by OccuLogix:

Estimated Enrollment: 180
Study Start Date: August 1999
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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
Study First Received: February 20, 2004
Last Updated: May 8, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014