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Long-Term Efficacy in AMD of Rheopheresis in North America

Sponsor
OccuLogix (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00380172
Collaborator
(none)
120
Enrollment
9
Locations
24
Duration (Months)
13.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Rheopheresis blood filtration
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Study Start Date :
Oct 1, 2005
Study Completion Date :
Oct 1, 2007

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retina Vitreous Associates Beverly Hills California United States 90211
2 Aran Eye Associates Coral Gables Florida United States 33134
3 Retina Health Care Ft. Myers Florida United States 33901
4 The Macula Center Palm Harbor Florida United States 34684
5 UIC Eye Center Chicago Illinois United States 60612
6 Macula Care New York New York United States 10021
7 Carolina Eye Associates Southern Pines North Carolina United States 28387
8 Associated Retinal Consultants Bala Cynwyd Pennsylvania United States 19004
9 W. Bradley Kates, MD Oakville, Ontario Canada L6H 3P1

Sponsors and Collaborators

  • OccuLogix

Investigators

  • Study Director: Nozhat Choudry', Ph.D., OccuLogix, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00380172
Other Study ID Numbers:
  • AMD-03-02
First Posted:
Sep 25, 2006
Last Update Posted:
Sep 25, 2006
Last Verified:
Sep 1, 2006
Keywords provided by , ,
AMD
Macular Degeneration
Retinal Degeneration
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Sep 25, 2006