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

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ClinicalTrials.gov Identifier: NCT00090532
Recruitment Status : Terminated (This study was terminated due to a lack of efficacy.)
First Posted : August 31, 2004
Last Update Posted : May 27, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: AG-013,958 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To evaluate the ocular and systemic safety of the study drug

Secondary Outcome Measures :
  1. To evaluate the visual acuity change after study treatment


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090532


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Locations
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United States, Arizona
Pfizer Investigational Site
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
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States
United States, Florida
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States
United States, Maryland
Pfizer Investigational Site
Chevy Chase, Maryland, United States
Pfizer Investigational Site
Hagerstown, Maryland, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Michigan
Pfizer Investigational Site
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
United States, New York
Pfizer Investigational Site
Slingerlands, New York, United States
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Huntersville, North Carolina, United States
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Lakewood, Ohio, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Chambersburg, Pennsylvania, United States
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
United States, Virginia
Pfizer Investigational Site
Fairfax, Virginia, United States
Australia, New South Wales
Pfizer Investigational Site
Sydney, New South Wales, Australia
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia
Netherlands
Pfizer Investigational Site
Nijmegen, Gld, Netherlands
Pfizer Investigational Site
Groningen, GR, Netherlands
Pfizer Investigational Site
Amsterdam, NH, Netherlands
Pfizer Investigational Site
Rotterdam, ZH, Netherlands
United Kingdom
Pfizer Investigational Site
Aberdeen, Scotland, United Kingdom
Pfizer Investigational Site
Bristol, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00090532     History of Changes
Other Study ID Numbers: A4321001
First Posted: August 31, 2004    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases