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A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

Sponsor
Eyetech Pharmaceuticals (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00354445
Collaborator
Pfizer (Industry)
1,000
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

Condition or Disease Intervention/Treatment Phase
  • Drug: pegaptanib sodium (Macugen)
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
Study Start Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subfoveal CNV secondary to AMD

    • At least 1 but not more than 3 prior treatments for AMD

    Exclusion Criteria:

    • Subfoveal scar or subfoveal atrophy

    • Significant media opacities, including cataract, which might interfere with visual acuity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Research Institute of Texas, LLC Abilene Texas United States 79606

    Sponsors and Collaborators

    • Eyetech Pharmaceuticals
    • Pfizer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00354445
    Other Study ID Numbers:
    • EOP1023
    First Posted:
    Jul 20, 2006
    Last Update Posted:
    Jan 15, 2007
    Last Verified:
    Jan 1, 2007
    Keywords provided by , ,
    Age-Related Macular Degeneration (AMD)
    pegaptanib sodium
    subfoveal CNV
    macugen
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Jan 15, 2007