Back to resultsRheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
Primary Purpose
Macular Degeneration
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rheopheresis blood filtration
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Dry AMD, Age-related Macular Degeneration, Rheopheresis
Eligibility 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
Sites / Locations
- Retina Vitreous Associates
- Aran Eye Associates
- Retina Health Care
- UIC Eye Center
- Macula Care
- Carolina Eye Associates
- Associated Retinal Consultants
- W. Bradley Kates, MD
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00078221
Brief Title
Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
OccuLogix
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Dry AMD, Age-related Macular Degeneration, Rheopheresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Rheopheresis blood filtration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irving Siegel, MD
Organizational Affiliation
OccuLogix
Official's Role
Study Director
Facility Information:
Facility Name
Retina Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Aran Eye Associates
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Retina Health Care
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
UIC Eye Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Macula Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Associated Retinal Consultants
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
W. Bradley Kates, MD
City
Oakville,
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12545682
Citation
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.
Results Reference
background
Links:
URL
http://www.rheo.com
Description
Related Info
Learn more about this trial
Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
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