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

Tracking Information

First Received Date ^ICMJE

February 20, 2004

Last Updated Date

May 8, 2008

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00078221 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Device: Rheopheresis blood filtration

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

180

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00078221

Responsible Party

Study ID Numbers ^ICMJE

AMD-02-99

Study Sponsor ^ICMJE

OccuLogix

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Irving Siegel, MD

OccuLogix

Information Provided By

OccuLogix

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP