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

Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00078221
• Other study ID #: AMD-02-99
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 20, 2004
• Last updated: May 8, 2008
• Start date: August 1999
• Est. completion date: December 2005

Study information

• Verified date: December 2005
• Source: OccuLogix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

• 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 Design

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Device:
• Rheopheresis blood filtration

Locations

Country	Name	City	State
Canada	W. Bradley Kates, MD	Oakville,	Ontario
United States	Associated Retinal Consultants	Bala Cynwyd	Pennsylvania
United States	Retina Vitreous Associates	Beverly Hills	California
United States	UIC Eye Center	Chicago	Illinois
United States	Aran Eye Associates	Coral Gables	Florida
United States	Retina Health Care	Ft. Myers	Florida
United States	Macula Care	New York	New York
United States	Carolina Eye Associates	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OccuLogix

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7. — View Citation