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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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AG-013,958
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
August 26, 2004
Last Updated
May 26, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00090532
Brief Title
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to a lack of efficacy.
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
155 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AG-013,958
Primary Outcome Measure Information:
Title
To evaluate the ocular and systemic safety of the study drug
Secondary Outcome Measure Information:
Title
To evaluate the visual acuity change after study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Oro Valley
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Sun City
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Pfizer Investigational Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Clair Shores
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Ypsilanti
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Slingerlands
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntersville
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Lakewood
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Chambersburg
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nijmegen
State/Province
Gld
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Groningen
State/Province
GR
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Amsterdam
State/Province
NH
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
State/Province
ZH
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Aberdeen
State/Province
Scotland
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4321001&StudyName=A+Study+Of+The+Safety+And+Efficacy+Of+AG%2D013%2C958+In+Subjects+With+Subfoveal+Choroidal+Neovascularization+Associated+With+Age%2DRelated+Macular+Degeneration++
Description
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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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