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)

OccuLogix9 sites in 2 countries120 target enrollmentOctober 2005

ConditionsMacular Degeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Macular Degeneration
Sponsor: OccuLogix
Enrollment: 120
Locations: 9
Primary Endpoint: 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.
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

October 2007

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OccuLogix

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

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.