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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	OccuLogix
Information provided by:	OccuLogix
ClinicalTrials.gov Identifier:	NCT00078221

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 III

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

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
	Retina Health Care
	Ft. Myers, Florida, United States, 33901
	Aran Eye Associates
	Coral Gables, Florida, United States, 33134

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

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	AMD-02-99
First Received:	February 20, 2004
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00078221
Health Authority:	United States: Food and Drug Administration

Keywords provided by OccuLogix:

Dry AMD

Age-related Macular Degeneration

Rheopheresis

Study placed in the following topic categories:

Eye Diseases

Retinal Degeneration

Macular Degeneration

Retinal Diseases

Retinal degeneration

ClinicalTrials.gov processed this record on November 20, 2008