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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00090532
• Other study ID #: A4321001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 26, 2004
• Last updated: May 26, 2011
• Start date: January 2004
• Est. completion date: August 2006

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• AG-013,958

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the ocular and systemic safety of the study drug
Secondary	To evaluate the visual acuity change after study treatment

External Links

•   To obtain contact information for a study center near you, click here.