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Phase II/III Study of Anti-VEGF in Neovascular AMD

Sponsor
Eyetech Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00021736
Collaborator
(none)
540
Enrollment
1
Location
12
Duration (Months)
45
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

Condition or Disease Intervention/Treatment Phase
  • Drug: EYE001 anti-VEGF aptamer
 Phase 2/Phase 3

Detailed Description

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: [predominantly classic (>50%) vs. minimally classic (1-49%) vs. purely occult (0%)], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Phase II/III Randomized, Double-Masked, Trial, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative AMD).
Study Start Date :
Jul 1, 2001
Study Completion Date :
Jul 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foundation for Fighting Blindness Baltimore Maryland United States

    Sponsors and Collaborators

    • Eyetech Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00021736
    Other Study ID Numbers:
    • EOP1004B
    First Posted:
    Aug 6, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jul 1, 2002
    Keywords provided by , ,
    choroidal neovascularization (CNV)
    subretinal neovascularization
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Jun 24, 2005