Long-Term Efficacy in AMD of Rheopheresis in North America
NCT ID: NCT00380172
Last Updated: 2006-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2005-10-31
2007-10-31
Brief Summary
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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
NONE
Interventions
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Rheopheresis blood filtration
Eligibility Criteria
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Inclusion Criteria
* Dry AMD in at least one eye.
* Available for study duration of 12 months.
* Weigh \>110 lbs.
* If on lipid-lowering medication must remain on for duration of trial. If not, must agree to not initate during trial.
* Normal Pt/ PTT. If on coumadin, at the discretion of the investigator.
* Must be highly motivated, alert and oriented, and able to provide consent.
* Agree to discontinue current ocular vitamin regimen and take uniform supplement provided by the sponsor.
Exclusion Criteria
* Condition limiting view of the fundus.
* Poor general health or unstable diseases.
* HCT \< 35%, evidence of active bleeding, platelet count \<100000 K/uL, prolonged Pt/ PTT, or significant coagupapathies.
* significant cardiac problems.
* Uncontrolled hypertension.
* History of CVA of TIA within a year.
* Significant hepatic, renal, or pulmonary disease, or insulin dependent diabetes.
* Allergy to fluorescein sodium and indocyanine green (ICG), heparin, ACDA, local anesthetics, or adhesive tape.
* Pregnant or breastfeeding women, or women of childbearing potential not using chemical or mechanical contraception.
* Investigation trial within 30 days.
* Major surgery within 30 days.
* Unwilling to adhere to visit schedule.
* Unstable medical of psychological condition.
0 Years
ALL
No
Sponsors
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OccuLogix
INDUSTRY
Principal Investigators
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Nozhat Choudry', Ph.D.
Role: STUDY_DIRECTOR
OccuLogix, Inc.
Locations
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Retina Vitreous Associates
Beverly Hills, California, United States
Aran Eye Associates
Coral Gables, Florida, United States
Retina Health Care
Fort Myers, Florida, United States
The Macula Center
Palm Harbor, Florida, United States
UIC Eye Center
Chicago, Illinois, United States
Macula Care
New York, New York, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Associated Retinal Consultants
Bala-Cynwyd, Pennsylvania, United States
W. Bradley Kates, MD
Oakville, Ontario, Canada
Countries
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Other Identifiers
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AMD-03-02
Identifier Type: -
Identifier Source: org_study_id