Safety and Effectiveness Investigation for Dry, Non-Exudative Age Related Macular Degeneration (AMD) Using Rheopheresis
NCT ID: NCT00460967
Last Updated: 2007-11-07
Study Results
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Basic Information
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SUSPENDED
PHASE3
325 participants
INTERVENTIONAL
2007-01-31
2009-12-31
Brief Summary
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Age-related macular degeneration (AMD) is the leading cause of late onset visual impairment and legal blindness in people 65 years of age or older in the United States. It is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. The degenerative retinal eye disease occurs in two forms - a non-exudative "dry" form and an exudative "wet" form which in an individual patient may also represent stages of the disease. Non-exudative AMD accounts for 80-90% of AMD cases and it involves a constellation of clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium (RPE) dropout, and geographic atrophy. Because of the overwhelming numbers of "dry" AMD subjects, the cumulative impact of this vision loss is significant.
There is no effective therapy for maintaining or improving vision associated with dry AMD. The only therapy for persons with dry AMD is an oral supplement containing high doses of antioxidants and zinc, which was tested by the National Eye Institute in a large, multi-center, double-masked, sham-controlled clinical trial1. This antioxidant therapy was shown to modestly retard the progression of dry AMD from an intermediate stage to the advanced stages and confirmed the benefit of antioxidant therapy in this disease. There is currently no FDA-approved therapy for the treatment of subjects with dry AMD.
Recently, the MIRA-1 modified per protocol population showed the effectiveness of Rheopheresis which is an application of selective therapeutic apheresis, namely double filtration plasmapheresis (DFPP) using a specifically designed filter for plasma filtration in subjects with non-exudative AMD. At one year the study reported with statistical significance (1) approximately a one line vision improvement in the Rheopheresis group versus no change in the Sham group and (2) 28% of subjects randomized to the active treatment gaining at least one line vision versus only 9% of subjects randomized to the sham treatment.
With a total of 300 subjects with dry AMD and visual acuity of 20/40-20/100 inclusive, the current investigation plans to prove the effectiveness of the Rheopheresis treatment on a larger scale. Each subject will receive a series of 8 treatments (either active treatment or sham treatment in a 2:1 ratio) for a period of approximately 2.5 months. In addition, a post-treatment ophthalmic evaluation will be performed 2 weeks after the 8th treatment (approximately 3 months after the baseline visit) and at the 6, 9 and 12 month visits. Comparing the one-year proportions of at least a 10-letter gain in ETDRS LogMar BCVA from baseline, the current investigation will show the effectiveness of Rheopheresis treatment (compared to sham treatment) for treating dry AMD subjects. Other secondary effectiveness endpoints, including mean changes and proportions of BCVA better than 20/40 at one year, will be analyzed to support the main investigation.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Rheopheresis treatment
Rheopheresis
8 rheopheresis treatments over 10 wks.
2
Sham treatment
Rheopheresis
Sham treatment
Interventions
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Rheopheresis
8 rheopheresis treatments over 10 wks.
Rheopheresis
Sham treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pigment epithelial detachment (PED) within 500 µm of the fovea
* Either eye with a diagnosis of exudative (wet) AMD
* Subjects having undergone cataract surgery less than 3 months prior to enrollment without an open posterior capsule
* Uncontrolled hypertension and/or diabetes
* Subjects with prolonged PT/PTT (unless the subject is taking warfarin), hematocrit \<35%, evidence of active bleeding, platelet count \<100,000/ml
50 Years
85 Years
ALL
No
Sponsors
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OccuLogix
INDUSTRY
Principal Investigators
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Nozhat Choudry, PhD
Role: STUDY_DIRECTOR
OccuLogix, Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Associated Retina Consultants, LTD.
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic, Department of Ophthalmology
Scottsdale, Arizona, United States
Southwest Kidney Institute, PLC, 2149 East Warner Rd. Ste. 109 & 110
Tempe, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
DSI
Brandon, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Vitreo-Retinal Associates
Worcester, Massachusetts, United States
University of Massachuesettes Medical Health Center
Worcester, Massachusetts, United States
Retinovitreous Associates, Ltd.
Cherry Hill, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
New York Blood Center
New York, New York, United States
Macula Care
New York, New York, United States
Vitreous Retina Macula Consultants
New York, New York, United States
Columbia University
New York, New York, United States
Retina Associates of Cleveland
Beachwood, Ohio, United States
Cleveland Clinic Foundation, Cole Eye Institute
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Retina Associates of Cleveland
Lakewood, Ohio, United States
University of Pennsylvannia Medical Center
Philadelphia, Pennsylvania, United States
Texas Retina Associates
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Memorial Hermann University of Texas Health Science Center
Houston, Texas, United States
The Methodist Hospital System
Houston, Texas, United States
Vitreoretinal Consultants
Houston, Texas, United States
Fairfax Pathology Associates, Ltd.
Annadale, Virginia, United States
Retina Group of Washington
Fairfax, Virginia, United States
Capital Health Systems, Ophthalmology & Visual Sciences
Halifax, Nova Scotia, Canada
Victoria General Hospital
Halifax, Nova Scotia, Canada
eyeMD Institute
Brampton, Ontario, Canada
Dr. Sapir
Oakville, Ontario, Canada
Rheopheresis Center Cologne
Cologne, , Germany
University of Cologne
Cologne, , Germany
Countries
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Other Identifiers
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RHEO-AMD 01-06
Identifier Type: -
Identifier Source: org_study_id