Long-Term Efficacy in AMD of Rheopheresis in North America

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Status

Unknown

Conditions

Macular Degeneration

Treatments

Device: Rheopheresis blood filtration

Study type

Interventional

Funder types

Industry

Identifiers

AMD-03-02

Details and patient eligibility

About

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.

Sex

All

Volunteers

No Healthy Volunteers

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.