Not Signed In -
Macular Degeneration |
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Clinical Trial: Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
This study is currently recruiting patients.
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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
Expected Total Enrollment: 180
Study start: August 1999; Expected 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
- 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
Location and Contact Information
Sue Howard, Asst Pjt Mgr 800-382-5556 sue.howard@vascularsciences.net
California
Retina Vitreous Associates, Beverly Hills, California, 90211, United States; Recruiting
David Boyer, MD, Principal Investigator
Florida
Retina Health Care, Ft. Myers, Florida, 33901, United States; Recruiting
Alexander Eaton, MD, Principal Investigator
Aran Eye Associates, Coral Gables, Florida, 33134, United States; Recruiting
Julio E. Perez, MD, Principal Investigator
Illinois
UIC Eye Center, Chicago, Illinois, 60612, United States; Recruiting
Larry Ulanski, MD, Sub-Investigator
New York
Macula Care, New York, New York, 10021, United States; Recruiting
Dan Rosberger, MD, Principal Investigator
North Carolina
Carolina Eye Associates, Southern Pines, North Carolina, 28387, United States; Recruiting
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
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
Susan Achal susan.achal@vascularsciences.net
W. Bradley Kates, MD, Principal Investigator
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.
Record last reviewed: October 2004
Last Updated: October 20, 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 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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