Long-Term Efficacy in AMD of Rheopheresis in North America

Not Applicable

• Conditions: Macular Degeneration

• Registration Number: NCT00380172
• Lead Sponsor: OccuLogix

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Status Verified: 2006-09
• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-21
• Last Update Submitted: 2006-09-21
• Study First Posted: 2006-09-25
• Last Update Posted: 2006-09-25
• Study Completion: 2007-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Retina Vitreous Associates; 🇺🇸 Beverly Hills, California, United States

Aran Eye Associates; 🇺🇸 Coral Gables, Florida, United States

Retina Health Care; 🇺🇸 Ft. Myers, Florida, United States

The Macula Center; 🇺🇸 Palm Harbor, Florida, United States

UIC Eye Center; 🇺🇸 Chicago, Illinois, United States

Macula Care; 🇺🇸 New York, New York, United States

Carolina Eye Associates; 🇺🇸 Southern Pines, North Carolina, United States

Associated Retinal Consultants; 🇺🇸 Bala Cynwyd, Pennsylvania, United States

W. Bradley Kates, MD; 🇨🇦 Oakville,, Ontario, Canada