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Long-Term Efficacy in AMD of Rheopheresis in North America

Primary Purpose

Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Rheopheresis blood filtration
Sponsored by
OccuLogix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Macular Degeneration, Retinal Degeneration

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Vitreous Associates
  • Aran Eye Associates
  • Retina Health Care
  • The Macula Center
  • UIC Eye Center
  • Macula Care
  • Carolina Eye Associates
  • Associated Retinal Consultants
  • W. Bradley Kates, MD

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 21, 2006
Last Updated
September 21, 2006
Sponsor
OccuLogix
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1. Study Identification

Unique Protocol Identification Number
NCT00380172
Brief Title
Long-Term Efficacy in AMD of Rheopheresis in North America
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
OccuLogix

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Macular Degeneration, Retinal Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Rheopheresis blood filtration
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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. Investigation trial within 30 days. Major surgery within 30 days. Unwilling to adhere to visit schedule. Unstable medical of psychological condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nozhat Choudry', Ph.D.
Organizational Affiliation
OccuLogix, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retina Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Aran Eye Associates
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Retina Health Care
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
The Macula Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
UIC Eye Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Macula Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Associated Retinal Consultants
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
W. Bradley Kates, MD
City
Oakville,
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada

12. IPD Sharing Statement

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Long-Term Efficacy in AMD of Rheopheresis in North America

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