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SEAGUL: Study Evaluating Genotypes Using Lucentis

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT00474695
Collaborator
Genentech, Inc. (Industry)
65
Enrollment
3
Locations
31
Duration (Months)
21.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Condition or Disease Intervention/Treatment Phase

Detailed Description

Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Study Design

Study Type:
Observational
Actual Enrollment :
65 participants
Time Perspective:
Prospective
Official Title:
VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
1

Active approved treatment

Drug: Lucentis
0.05 mg intravitreal injection
Other Names:
  • ranibizumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity [4 months]

    Secondary Outcome Measures

    1. Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity [12 months]

    Eligibility Criteria

    Criteria

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

    • Treatment naive AMD patients;

    • At least 50 years of age;

    • Visual acuity between 20/40 and 20/320

    Exclusion Criteria:

    • Pregnancy;

    • Prior enrollment in a ranibizumab clinical trial;

    • Previous therapy in either eye for AMD;

    • Concurrent eye disease that could compromise visual acuity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Retina Consultants Santa Barbara California United States 93103
    2 Porter Adventist Hospital Denver Colorado United States 80210
    3 University of Utah, Moran Eye Center Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • University of Utah
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Paul Bernstein, MD, PhD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul S. Bernstein, Professor, Ophthalmology, University of Utah
    ClinicalTrials.gov Identifier:
    NCT00474695
    Other Study ID Numbers:
    • 21441
    • SEAGUL
    First Posted:
    May 17, 2007
    Last Update Posted:
    Feb 11, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Paul S. Bernstein, Professor, Ophthalmology, University of Utah
    Exudative age-related macular degeneration
    Additional relevant MeSH terms:
    Macular Degeneration
    Ranibizumab

    Study Results

    No Results Posted as of Feb 11, 2015