NCT00078221

Brief Summary

AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_3

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2004

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

May 9, 2008

Status Verified

December 1, 2005

First QC Date

February 20, 2004

Last Update Submit

May 8, 2008

Conditions

Macular Degeneration

Keywords

Dry AMDAge-related Macular DegenerationRheopheresis

Interventions

Rheopheresis blood filtrationDEVICE

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Age 50-85 * Diagnosis of Dry AMD * BCVA between 20/32 and 20/125 in at least one eye * Numerous large plaques (soft drusen) * No history of HIV, Hepatitis B or C * Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Aran Eye Associates

Coral Gables, Florida, 33134, United States

Location

Retina Health Care

Fort Myers, Florida, 33901, United States

Location

UIC Eye Center

Chicago, Illinois, 60612, United States

Location

Macula Care

New York, New York, 10021, United States

Location

Carolina Eye Associates

Southern Pines, North Carolina, 28387, United States

Location

Associated Retinal Consultants

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

W. Bradley Kates, MD

Oakville, Ontario, L6H 3P1, Canada

Location

Related Publications (1)

  • Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7.

    PMID: 12545682BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Irving Siegel, MD

    OccuLogix

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2004

First Posted

March 1, 2004

Study Start

August 1, 1999

Study Completion

December 1, 2005

Last Updated

May 9, 2008

Record last verified: 2005-12

Locations

CA(1)US(7)