Long-Term Efficacy in AMD of Rheopheresis in North America

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)

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.

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.