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 terminated.
(This study was terminated due to a lack of efficacy.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00090532
First received: August 26, 2004
Last updated: May 26, 2011
Last verified: May 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00090532     History of Changes
Other Study ID Numbers: A4321001
Study First Received: August 26, 2004
Last Updated: May 26, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 27, 2014