A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

May 26, 2011 updated by: Pfizer

A Phase 1/2, Randomized, Masked, Single and Multiple-Dose, Sequential Dose-Escalation Study of the Safety an Efficacy of AG-013958 in Subjects With Subfoveal Choroidal Neovascularization Associated With Age-related Macular Degeneration

AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

155

Phase

  • Phase 2
  • Phase 1

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Pfizer Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia
        • Pfizer Investigational Site
  • Netherlands
    • GR
      • Groningen, GR, Netherlands
        • Pfizer Investigational Site
    • Gld
      • Nijmegen, Gld, Netherlands
        • Pfizer Investigational Site
    • NH
      • Amsterdam, NH, Netherlands
        • Pfizer Investigational Site
    • ZH
      • Rotterdam, ZH, Netherlands
        • Pfizer Investigational Site
  • United Kingdom
      • Bristol, United Kingdom
        • Pfizer Investigational Site
      • London, United Kingdom
        • Pfizer Investigational Site
    • Scotland
      • Aberdeen, Scotland, United Kingdom
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Pfizer Investigational Site
      • Oro Valley, Arizona, United States
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
      • Sun City, Arizona, United States
        • Pfizer Investigational Site
      • Tucson, Arizona, United States
        • Pfizer Investigational Site
      • Tuscon, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States
        • Pfizer Investigational Site
    • Florida
      • Fort Myers, Florida, United States
        • Pfizer Investigational Site
      • Tampa, Florida, United States
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States
        • Pfizer Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States
        • Pfizer Investigational Site
      • Hagerstown, Maryland, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Pfizer Investigational Site
      • Livonia, Michigan, United States
        • Pfizer Investigational Site
      • Rochester, Michigan, United States
        • Pfizer Investigational Site
      • Royal Oak, Michigan, United States
        • Pfizer Investigational Site
      • St. Clair Shores, Michigan, United States
        • Pfizer Investigational Site
      • Ypsilanti, Michigan, United States
        • Pfizer Investigational Site
    • New York
      • Slingerlands, New York, United States
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pfizer Investigational Site
      • Huntersville, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Pfizer Investigational Site
      • Lakewood, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States
        • Pfizer Investigational Site
    • Virginia
      • Fairfax, Virginia, United States
        • Pfizer Investigational Site

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and/or female subjects >=55 years of age
  • Subfoveal choroidal neovascularization complicating age-related macular degeneration
  • Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria:

  • Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the ocular and systemic safety of the study drug

Secondary Outcome Measures

Outcome Measure
To evaluate the visual acuity change after study treatment

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2004

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 26, 2004

First Submitted That Met QC Criteria

August 30, 2004

First Posted (Estimate)

August 31, 2004

Study Record Updates

Last Update Posted (Estimate)

May 27, 2011

Last Update Submitted That Met QC Criteria

May 26, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4321001

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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