NCT00090532

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2004

Typical duration for phase_1

Geographic Reach
4 countries

39 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

First QC Date

August 26, 2004

Last Update Submit

May 26, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the ocular and systemic safety of the study drug

Secondary Outcomes (1)

  • To evaluate the visual acuity change after study treatment

Interventions

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Pfizer Investigational Site

Mesa, Arizona, United States

Location

Pfizer Investigational Site

Oro Valley, Arizona, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, United States

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Pfizer Investigational Site

Sun City, Arizona, United States

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Pfizer Investigational Site

Tucson, Arizona, United States

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Pfizer Investigational Site

Tuscon, Arizona, United States

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Pfizer Investigational Site

Beverly Hills, California, United States

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Pfizer Investigational Site

Fort Myers, Florida, United States

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Pfizer Investigational Site

Tampa, Florida, United States

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Pfizer Investigational Site

Iowa City, Iowa, United States

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Pfizer Investigational Site

Chevy Chase, Maryland, United States

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Pfizer Investigational Site

Hagerstown, Maryland, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, United States

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Pfizer Investigational Site

Ann Arbor, Michigan, United States

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Pfizer Investigational Site

Livonia, Michigan, United States

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Pfizer Investigational Site

Rochester, Michigan, United States

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Pfizer Investigational Site

Royal Oak, Michigan, United States

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Pfizer Investigational Site

Saint Clair Shores, Michigan, United States

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Pfizer Investigational Site

Ypsilanti, Michigan, United States

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Pfizer Investigational Site

Slingerlands, New York, United States

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Pfizer Investigational Site

Charlotte, North Carolina, United States

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Pfizer Investigational Site

Huntersville, North Carolina, United States

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Pfizer Investigational Site

Cleveland, Ohio, United States

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Pfizer Investigational Site

Lakewood, Ohio, United States

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Pfizer Investigational Site

Portland, Oregon, United States

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Pfizer Investigational Site

Chambersburg, Pennsylvania, United States

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Pfizer Investigational Site

Columbia, South Carolina, United States

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Pfizer Investigational Site

Knoxville, Tennessee, United States

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Pfizer Investigational Site

Houston, Texas, United States

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Pfizer Investigational Site

Fairfax, Virginia, United States

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Pfizer Investigational Site

Sydney, New South Wales, Australia

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Pfizer Investigational Site

East Melbourne, Victoria, Australia

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Pfizer Investigational Site

Nijmegen, Gelderland, Netherlands

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Pfizer Investigational Site

Amsterdam, North Holland, Netherlands

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Pfizer Investigational Site

Groningen, Provincie Groningen, Netherlands

Location

Pfizer Investigational Site

Rotterdam, South Holland, Netherlands

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Pfizer Investigational Site

Aberdeen, Scotland, United Kingdom

Location

Pfizer Investigational Site

Bristol, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2004

First Posted

August 31, 2004

Study Start

January 1, 2004

Study Completion

August 1, 2006

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations