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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 26, 2004

Last Updated Date

May 4, 2007

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

To evaluate the ocular and systemic safety of the study drug

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00090532 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the visual acuity change after study treatment

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Age-Related Macular Degeneration

Intervention ^†

Drug: AG-013,958

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

155

Completion Date

August 2006

Primary Completion Date

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Netherlands, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090532

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.