Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

NCT ID: NCT00088192

Last Updated: 2005-08-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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AMD Age-Related Macular Degeneration Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pegaptanib sodium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Best corrected visual acuity in the study eye between 20/40 and 20/320.
* Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV.
* Any subretinal hemorrhage must comprise no more than 50% of total lesion size.

General Criteria:

* Patients of either gender, aged greater than 50 years.
* Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
* Written informed consent.

Exclusion Criteria

* Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
* Patients who are eligible for PDT with Visudyne
* Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Doheny Eye Institute

Los Angeles, California, United States

Site Status

Connecticut Retina Consultants, L.L.C.

Bridgeport, Connecticut, United States

Site Status

New England Retina Associates

Hamden, Connecticut, United States

Site Status

Retina Health Center

Fort Myers, Florida, United States

Site Status

Retina Associates

New Orleans, Louisiana, United States

Site Status

Cumberland Valley Retina Center

Hagerstown, Maryland, United States

Site Status

New England Eye Center

Boston, Massachusetts, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Associated Retinal Consultants

Royal Oak, Michigan, United States

Site Status

Eye Foundation of Kansas City

Kansas City, Missouri, United States

Site Status

The Eye Center of Concord

Concord, New Hampshire, United States

Site Status

Vitreo- Retinal Assoc. of NJ

Belleville, New Jersey, United States

Site Status

Retina Associates of New Jersey, P.A.

Teaneck, New Jersey, United States

Site Status

L.I. Vitreo-Retinal Consultants

Great Neck, New York, United States

Site Status

Retina Associates of Cleveland Inc.

Lakewood, Ohio, United States

Site Status

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

The Casey Eye Institute

Portland, Oregon, United States

Site Status

Palmetto Retina Center

Columbia, South Carolina, United States

Site Status

Valley Retina Associates, P.A.

McAllen, Texas, United States

Site Status

University of Vermont College of Medicine

Burlington, Vermont, United States

Site Status

Countries

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United States

Related Links

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http://www.eyetech.com

Sponsors Website

Other Identifiers

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EOP1010

Identifier Type: -

Identifier Source: org_study_id