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

August 29, 2005 updated by: Eyetech Pharmaceuticals

An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Doheny Eye Institute
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Retina Consultants, L.L.C.
      • Hamden, Connecticut, United States, 06518
        • New England Retina Associates
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Retina Health Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70155
        • Retina Associates
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Eye Foundation of Kansas City
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • The Eye Center of Concord
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Vitreo- Retinal Assoc. of NJ
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey, P.A.
    • New York
      • Great Neck, New York, United States, 11021
        • L.I. Vitreo-Retinal Consultants
    • Ohio
      • Lakewood, Ohio, United States, 44107
        • Retina Associates of Cleveland Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • The Casey Eye Institute
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Palmetto Retina Center
    • Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Associates, P.A.
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyetech Pharmaceuticals

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Registration Dates

First Submitted

July 21, 2004

First Submitted That Met QC Criteria

July 21, 2004

First Posted (Estimate)

July 22, 2004

Study Record Updates

Last Update Posted (Estimate)

August 30, 2005

Last Update Submitted That Met QC Criteria

August 29, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOP1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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