Long-Term Efficacy in AMD of Rheopheresis in North America
This trial is active, not recruiting.
|Treatment||rheopheresis blood filtration|
|Start date||October 2005|
|End date||October 2007|
|Trial size||120 participants|
|Trial identifier||NCT00380172, AMD-03-02|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Beverly Hills, CA||Retina Vitreous Associates||no longer recruiting|
|Coral Gables, FL||Aran Eye Associates||no longer recruiting|
|Ft. Myers, FL||Retina Health Care||no longer recruiting|
|Palm Harbor, FL||The Macula Center||no longer recruiting|
|Chicago, IL||UIC Eye Center||no longer recruiting|
|New York, NY||Macula Care||no longer recruiting|
|Southern Pines, NC||Carolina Eye Associates||no longer recruiting|
|Bala Cynwyd, PA||Associated Retinal Consultants||no longer recruiting|
|Oakville,, Canada||W. Bradley Kates, MD||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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.
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.
Male or female participants of any age.
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.
|Official title||A Multicenter, Open Label, Prospective Study to Determine Safety and Efficacy Over an Additional 12-Month Period With Non-Exudative Age-Related Macular Degeneration (With Follow-on to 12-Months)|
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