Long-Term Efficacy in AMD of Rheopheresis in North America

Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00380172
• Other study ID #: AMD-03-02
• Status: Active, not recruiting
• Phase: N/A
• First received: September 21, 2006
• Last updated: September 21, 2006
• Start date: October 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2006
• Source: OccuLogix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Device:
• Rheopheresis blood filtration

Locations

Country	Name	City	State
Canada	W. Bradley Kates, MD	Oakville,	Ontario
United States	Associated Retinal Consultants	Bala Cynwyd	Pennsylvania
United States	Retina Vitreous Associates	Beverly Hills	California
United States	UIC Eye Center	Chicago	Illinois
United States	Aran Eye Associates	Coral Gables	Florida
United States	Retina Health Care	Ft. Myers	Florida
United States	Macula Care	New York	New York
United States	The Macula Center	Palm Harbor	Florida
United States	Carolina Eye Associates	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OccuLogix

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.