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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00090532

Purpose

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	Intervention	Phase
Age-Related Macular Degeneration	Drug: AG-013,958	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the ocular and systemic safety of the study drug

Secondary Outcome Measures:

To evaluate the visual acuity change after study treatment

Estimated Enrollment:	155
Study Start Date:	January 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090532

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Locations

United States, Arizona
Pfizer Investigational Site
Oro Valley, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Tuscon, Arizona, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Sun City, Arizona, United States
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States
United States, Maryland
Pfizer Investigational Site
Hagerstown, Maryland, United States
Pfizer Investigational Site
Chevy Chase, 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
Ypsilanti, 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
Livonia, 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, Gld
Pfizer Investigational Site
Nijmegen, Gld, Netherlands
Netherlands, GR
Pfizer Investigational Site
Groningen, GR, Netherlands
Netherlands, NH
Pfizer Investigational Site
Amsterdam, NH, Netherlands
Netherlands, ZH
Pfizer Investigational Site
Rotterdam, ZH, Netherlands
United Kingdom
Pfizer Investigational Site
Bristol, United Kingdom
Pfizer Investigational Site
London, United Kingdom
United Kingdom, Scotland
Pfizer Investigational Site
Aberdeen, Scotland, United Kingdom

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A4321001
Study First Received:	August 26, 2004
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00090532 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on May 14, 2009