<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682382</url>
  </required_header>
  <id_info>
    <org_study_id>SQNM-AMD-103</org_study_id>
    <nct_id>NCT01682382</nct_id>
  </id_info>
  <brief_title>Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sequenom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sequenom, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular&#xD;
      measurements, will provide a blood and cheek cell sample, and will have macular pigment&#xD;
      optical density (MPOD) measured to determine if there is an association between genetics,&#xD;
      MPOD and the risk of progression to wet AMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association between a genetic variant in the CFH gene and risk of progression to CNV</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genetic correlation between MPOD and risk of progression to CNV</measure>
    <time_frame>baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Choroidal Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>choroidal neovascular (CNV) AMD subjects</arm_group_label>
    <description>Subjects diagnosed with CNV (AREDS Grade 4b)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dry AMD subjects</arm_group_label>
    <description>Subjects diagnosed with dry AMD (AREDS Grade 3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>age-matched controls</arm_group_label>
    <description>Subjects without AMD (AREDS Grade 1)</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA extracted from whole blood and buccal cells will be analyzed. Remnant samples will be&#xD;
      stored for future research in AMD.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Non-Hispanic Caucasian subjects 60 years of age and older diagnosed with either CNV or dry&#xD;
        AMD and a cohort of age-matched controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject is diagnosed with either CNV, dry AMD or is an age-matched control&#xD;
&#xD;
          -  self reported as non-Hispanic Caucasian&#xD;
&#xD;
          -  60 years of age or older&#xD;
&#xD;
          -  provides signed and dated informed consent&#xD;
&#xD;
          -  agrees to provide 10 mL of whole blood and two buccal swabs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous donation under this protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Morris Eye Group</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>age-related macular degeneration</keyword>
  <keyword>choroidal neovascular age-related macular degeneration</keyword>
  <keyword>genetics</keyword>
  <keyword>macular pigment optical density (MPOD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682382
org study id: SQNM-AMD-103
nct id: NCT01682382
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Association between a genetic variant in the CFH gene and risk of progression to CNV
time frame: Baseline
description: 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
measure: Genetic correlation between MPOD and risk of progression to CNV
time frame: baseline
description: 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
arm group label: choroidal neovascular (CNV) AMD subjects
description: Subjects diagnosed with CNV (AREDS Grade 4b)
arm group label: dry AMD subjects
description: Subjects diagnosed with dry AMD (AREDS Grade 3)
arm group label: age-matched controls
description: Subjects without AMD (AREDS Grade 1)
DNA extracted from whole blood and buccal cells will be analyzed. Remnant samples will be
      stored for future research in AMD.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration