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
| Verified date | May 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 155 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Netherlands, United Kingdom,
| 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 |
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