Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)

NCT ID: NCT00078221

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dry AMD Age-related Macular Degeneration Rheopheresis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rheopheresis blood filtration

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

OccuLogix

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Irving Siegel, MD

Role: STUDY_DIRECTOR

OccuLogix

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Retina Vitreous Associates

Beverly Hills, California, United States

Site Status

Aran Eye Associates

Coral Gables, Florida, United States

Site Status

Retina Health Care

Fort Myers, Florida, United States

Site Status

UIC Eye Center

Chicago, Illinois, United States

Site Status

Macula Care

New York, New York, United States

Site Status

Carolina Eye Associates

Southern Pines, North Carolina, United States

Site Status

Associated Retinal Consultants

Bala-Cynwyd, Pennsylvania, United States

Site Status

W. Bradley Kates, MD

Oakville, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12545682 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMD-02-99

Identifier Type: -

Identifier Source: org_study_id