Long-Term Efficacy in AMD of Rheopheresis in North America (NCT00380172) | Clinical Trial Compass
UnknownNot Applicable
Long-Term Efficacy in AMD of Rheopheresis in North America
United States120 participantsStarted 2005-10
Plain-language 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.
Who can participate
Age range0 Years
SexALL
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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.
What they're measuring
1
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.