A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00090532
Collaborator
(none)
155
39
31
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2004
Actual Study Completion Date
:
Aug 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Mesa | Arizona | United States | |
| 2 | Pfizer Investigational Site | Oro Valley | Arizona | United States | |
| 3 | Pfizer Investigational Site | Phoenix | Arizona | United States | |
| 4 | Pfizer Investigational Site | Sun City | Arizona | United States | |
| 5 | Pfizer Investigational Site | Tucson | Arizona | United States | |
| 6 | Pfizer Investigational Site | Tuscon | Arizona | United States | |
| 7 | Pfizer Investigational Site | Beverly Hills | California | United States | |
| 8 | Pfizer Investigational Site | Fort Myers | Florida | United States | |
| 9 | Pfizer Investigational Site | Tampa | Florida | United States | |
| 10 | Pfizer Investigational Site | Iowa City | Iowa | United States | |
| 11 | Pfizer Investigational Site | Chevy Chase | Maryland | United States | |
| 12 | Pfizer Investigational Site | Hagerstown | Maryland | United States | |
| 13 | Pfizer Investigational Site | Boston | Massachusetts | United States | |
| 14 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | |
| 15 | Pfizer Investigational Site | Livonia | Michigan | United States | |
| 16 | Pfizer Investigational Site | Rochester | Michigan | United States | |
| 17 | Pfizer Investigational Site | Royal Oak | Michigan | United States | |
| 18 | Pfizer Investigational Site | St. Clair Shores | Michigan | United States | |
| 19 | Pfizer Investigational Site | Ypsilanti | Michigan | United States | |
| 20 | Pfizer Investigational Site | Slingerlands | New York | United States | |
| 21 | Pfizer Investigational Site | Charlotte | North Carolina | United States | |
| 22 | Pfizer Investigational Site | Huntersville | North Carolina | United States | |
| 23 | Pfizer Investigational Site | Cleveland | Ohio | United States | |
| 24 | Pfizer Investigational Site | Lakewood | Ohio | United States | |
| 25 | Pfizer Investigational Site | Portland | Oregon | United States | |
| 26 | Pfizer Investigational Site | Chambersburg | Pennsylvania | United States | |
| 27 | Pfizer Investigational Site | Columbia | South Carolina | United States | |
| 28 | Pfizer Investigational Site | Knoxville | Tennessee | United States | |
| 29 | Pfizer Investigational Site | Houston | Texas | United States | |
| 30 | Pfizer Investigational Site | Fairfax | Virginia | United States | |
| 31 | Pfizer Investigational Site | Sydney | New South Wales | Australia | |
| 32 | Pfizer Investigational Site | East Melbourne | Victoria | Australia | |
| 33 | Pfizer Investigational Site | Nijmegen | Gld | Netherlands | |
| 34 | Pfizer Investigational Site | Groningen | GR | Netherlands | |
| 35 | Pfizer Investigational Site | Amsterdam | NH | Netherlands | |
| 36 | Pfizer Investigational Site | Rotterdam | ZH | Netherlands | |
| 37 | Pfizer Investigational Site | Aberdeen | Scotland | United Kingdom | |
| 38 | Pfizer Investigational Site | Bristol | United Kingdom | ||
| 39 | Pfizer Investigational Site | London | United Kingdom |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00090532
Other Study ID Numbers:
- A4321001
First Posted:
Aug 31, 2004
Last Update Posted:
May 27, 2011
Last Verified:
May 1, 2011
Additional relevant MeSH terms: