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

This study is currently recruiting patients.

Sponsored by: Vascular Sciences Corporation
Information provided by: Vascular Sciences Corporation

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 Treatment or Intervention Phase
Macular Degeneration
 Device: Rheopheresis blood filtration
Phase III

MedlinePlus related topics:  Macular Degeneration

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

Further Study Details: 

Expected Total Enrollment:  180

Study start: August 1999;  Study completion: June 2006
Last follow-up: February 2006;  Data entry closure: June 2006

Eligibility

Ages Eligible for Study:  50 Years   -   85 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria


Location and Contact Information

Karen J. Coyle, RAC      800-382-5556    karen.coyle@vascularsciences.net
Sue Howard, Asst Pjt Mgr      800-382-5556    sue.howard@vascularsciences.net

California
      Retina Vitreous Associates, Beverly Hills,  California,  90211,  United States; Recruiting
Joe Martinez, Coordinator  310-854-6201    jmdoubt@aol.com 
David Boyer, MD,  Principal Investigator

Florida
      Retina Health Care, Ft. Myers,  Florida,  33901,  United States; Recruiting
Chris Elkins, Coordinator  239-337-3337  Ext. 220    chrisehrc@yahoo.com 
Alexander Eaton, MD,  Principal Investigator

      Aran Eye Associates, Coral Gables,  Florida,  33134,  United States; Recruiting
Liset Zaldivar, Coordinator  305-442-2020    lzaldivar1097@yahoo.com 
Julio E. Perez, MD,  Principal Investigator

Illinois
      UIC Eye Center, Chicago,  Illinois,  60612,  United States; Recruiting
Jeff Parker, Coordinator  312-996-4747    jparke10@uic.edu 
Larry Ulanski, MD,  Sub-Investigator

New York
      Macula Care, New York,  New York,  10021,  United States; Recruiting
Wanda Boyd, Coordinator  212-439-9600    wcarrasquillo@yahoo.com 
Dan Rosberger, MD,  Principal Investigator

North Carolina
      Carolina Eye Associates, Southern Pines,  North Carolina,  28387,  United States; Recruiting
Avie Banks, Coordinator  910-295-2100  Ext. 881    avie_banks@carolinaeye.com 
Carol Jones, CRT, RN, BSN  910-295-2100  Ext. 605    carol.jones@vascularsciences.net 
Gregory Mincey, MD,  Principal Investigator

Pennsylvania
      Associated Retinal Consultants, Bala Cynwyd,  Pennsylvania,  19004,  United States; Recruiting
Shae Reber, Coordinator  610-660-0446    kennedyshae@hotmail.com 
Tom Walker, Photographer  610 / 660-0446    twalker@medsynergies.com 
Jay Federman, MD,  Principal Investigator

Canada, Ontario
      W. Bradley Kates, MD, Oakville,  Ontario,  L6H 3P1,  Canada; Recruiting
Linda Birk, Coordinator  416 / 970-7123    lbirk@haltonhealthcare.on.ca 
Susan Achal   susan.achal@vascularsciences.net 
W. Bradley Kates, MD,  Principal Investigator

Study chairs or principal investigators

Irving Siegel, MD,  Study Director,  Vascular Sciences Corporation   

More Information

http://www.amdstudy.com

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
Record last reviewed:  October 2004
Record first received:  February 20, 2004
ClinicalTrials.gov Identifier:  NCT00078221
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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