Long-Term Efficacy in AMD of Rheopheresis in North America
Not Applicable
- Conditions
- Macular Degeneration
- Registration Number
- NCT00380172
- Lead Sponsor
- OccuLogix
- Brief Summary
The purpose of these studies are to evaluate the effect on vision in subjects with AMD who received active and placebo treatment in the MIRA-1 study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Must have participated in treatment arm of MIRA-1 trial and completed 4 treatments and 6 and 9 month follow up visits.
- 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
- Both eyes wet AMD.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the change from baseline and ETDRS visual acuity in subjects with non-exudative AMD who participated in AMD-02-99.
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to evaluate the safety of rheopheresis filtration treatments in subjects with non-exudative AMD as measured by AE's early DC's and Lab evaluations.
Trial Locations
- Locations (9)
UIC Eye Center
🇺🇸Chicago, Illinois, United States
The Macula Center
🇺🇸Palm Harbor, Florida, United States
W. Bradley Kates, MD
🇨🇦Oakville,, Ontario, Canada
Carolina Eye Associates
🇺🇸Southern Pines, North Carolina, United States
Retina Vitreous Associates
🇺🇸Beverly Hills, California, United States
Macula Care
🇺🇸New York, New York, United States
Aran Eye Associates
🇺🇸Coral Gables, Florida, United States
Associated Retinal Consultants
🇺🇸Bala Cynwyd, Pennsylvania, United States
Retina Health Care
🇺🇸Ft. Myers, Florida, United States