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Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)

Sponsor
Sequenom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01682382
Collaborator
(none)
45
Enrollment
1
Location
14
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular measurements, will provide a blood and cheek cell sample, and will have macular pigment optical density (MPOD) measured to determine if there is an association between genetics, MPOD and the risk of progression to wet AMD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collection of Whole Blood Specimens and Buccal Swabs From Subjects Diagnosed With CNV AMD, Dry AMD, and Age-Matched Controls to Assess the Association of Genetic Variants in Complement Factor H With Risk of Progression to CNV.
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2013
    Actual Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    choroidal neovascular (CNV) AMD subjects

    Subjects diagnosed with CNV (AREDS Grade 4b)
    dry AMD subjects

    Subjects diagnosed with dry AMD (AREDS Grade 3)
    age-matched controls

    Subjects without AMD (AREDS Grade 1)

    Outcome Measures

    Primary Outcome Measures

    1. Association between a genetic variant in the CFH gene and risk of progression to CNV [Baseline]

      DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate a genetic variant in the CFH gene and its association with risk of progression to CNV

    Secondary Outcome Measures

    1. Genetic correlation between MPOD and risk of progression to CNV [baseline]

      DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate the correlation between genetics, MPOD, and risk of progression to CNV

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • subject is diagnosed with either CNV, dry AMD or is an age-matched control

    • self reported as non-Hispanic Caucasian

    • 60 years of age or older

    • provides signed and dated informed consent

    • agrees to provide 10 mL of whole blood and two buccal swabs

    Exclusion Criteria:
    • previous donation under this protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Morris Eye Group Encinitas California United States 92024

    Sponsors and Collaborators

    • Sequenom, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sequenom, Inc.
    ClinicalTrials.gov Identifier:
    NCT01682382
    Other Study ID Numbers:
    • SQNM-AMD-103
    First Posted:
    Sep 10, 2012
    Last Update Posted:
    Jan 20, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Sequenom, Inc.
    age-related macular degeneration
    choroidal neovascular age-related macular degeneration
    genetics
    macular pigment optical density (MPOD)
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration

    Study Results

    No Results Posted as of Jan 20, 2014