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

May 8, 2008 updated by: OccuLogix
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville,, Ontario, Canada, L6H 3P1
        • W. Bradley Kates, MD
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Aran Eye Associates
      • Ft. Myers, Florida, United States, 33901
        • Retina Health Care
    • Illinois
      • Chicago, Illinois, United States, 60612
        • UIC Eye Center
    • New York
      • New York, New York, United States, 10021
        • Macula Care
    • North Carolina
      • Southern Pines, North Carolina, United States, 28387
        • Carolina Eye Associates
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Associated Retinal Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OccuLogix

Investigators

  • Study Director: Irving Siegel, MD, OccuLogix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 20, 2004

First Submitted That Met QC Criteria

February 27, 2004

First Posted (ESTIMATE)

March 1, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 8, 2008

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMD-02-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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