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Status:

UNKNOWN

Long-Term Efficacy in AMD of Rheopheresis in North America

Lead Sponsor:

OccuLogix

Conditions:

Macular Degeneration

Eligibility:

All Genders

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2005

Trial Type :

INTERVENTIONAL

End Date :

October 1 2007

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00380172

Start Date

October 1 2005

End Date

October 1 2007

Last Update

September 25 2006

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Retina Vitreous Associates

Beverly Hills, California, United States, 90211

2

Aran Eye Associates

Coral Gables, Florida, United States, 33134

3

Retina Health Care

Fort Myers, Florida, United States, 33901

4

The Macula Center

Palm Harbor, Florida, United States, 34684