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

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00090532

Purpose

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	Intervention	Phase
Age-Related Macular Degeneration	Drug: AG-013,958	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

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

Estimated Enrollment:	155
Study Start Date:	January 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090532

Show 39 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A4321001
Study First Received:	August 26, 2004
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00090532
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration

Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009