Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatment rheopheresis blood filtration
Sponsor OccuLogix
Start date October 2005
End date October 2007
Trial size 120 participants
Trial identifier NCT00380172, AMD-03-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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.
time frame:

Secondary Outcomes

Measure
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.
time frame:

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by OccuLogix.