Clinical trial NCT00090532: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-08-31
Enrollment: 155
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the ocular and systemic safety of the study drug
Secondary outcomes:
measure: To evaluate the visual acuity change after study treatment
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Oro Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Chevy Chase
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Livonia
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Clair Shores
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ypsilanti
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Slingerlands
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Chambersburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Sydney
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
state: Gld
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
state: GR
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: NH
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
state: ZH
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: