<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/NCT03024424</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 60413</org_study_id>
    <nct_id>NCT03024424</nct_id>
  </id_info>
  <brief_title>Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD</brief_title>
  <official_title>Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are:&#xD;
&#xD;
      To assess the impact of genetic testing based on how it alters behaviors, to assess the&#xD;
      utility of serum biomarker measurement in combination with genetic testing, to assess the&#xD;
      utility of genetic counseling in personal analysis of risk for age-related macular&#xD;
      degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal&#xD;
      neovascularization (CNV).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in carotenoid levels in the skin</measure>
    <time_frame>Twelve months</time_frame>
    <description>Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in carotenoid levels in the eyes</measure>
    <time_frame>Twelve months</time_frame>
    <description>Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <condition>Choroidal Neovascularization</condition>
  <condition>Genetic Counseling</condition>
  <arm_group>
    <arm_group_label>Early disclosure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early disclosure group receives results of genetic testing at Week 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late disclosure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Late disclosure group receives results of genetic testing at final study visit (Month 12)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early disclosure</intervention_name>
    <arm_group_label>Early disclosure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Late disclosure</intervention_name>
    <arm_group_label>Late disclosure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian (this particular genetic test is only validated in Caucasians) Participants&#xD;
             can have a positive family history of AMD but this is not necessary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a personal history of AMD are not eligible. Non-caucasian individuals&#xD;
             are not eligible. Employees of the Moran Eye Center are not eligible.&#xD;
&#xD;
          -  Individuals with a personal history of previous AMD genetic risk testing are not&#xD;
             eligible.&#xD;
&#xD;
          -  Individuals with a major psychiatric disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul S. Bernstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Moran Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah John A. Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Paul S. Bernstein</investigator_full_name>
    <investigator_title>Professor, Ophthalmology/Visual Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Neovascularization, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03024424
org study id: IRB 60413
nct id: NCT03024424
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goals of this study are:

      To assess the impact of genetic testing based on how it alters behaviors, to assess the
      utility of serum biomarker measurement in combination with genetic testing, to assess the
      utility of genetic counseling in personal analysis of risk for age-related macular
      degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal
      neovascularization (CNV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Masking is applicable to risk of age-related macular degeneration, not to intervention assignment.
measure: Change in carotenoid levels in the skin
time frame: Twelve months
description: Carotenoid levels in the skin are measured non-invasively at baseline and again at 12 months. Carotenoid levels are a biomarker of fruit and vegetable intake.
measure: Change in carotenoid levels in the eyes
time frame: Twelve months
description: Carotenoid levels in the eyes are measured non-invasively at baseline and again at 12 months.
arm group label: Early disclosure
arm group type: Experimental
description: Early disclosure group receives results of genetic testing at Week 4
arm group label: Late disclosure
arm group type: Active Comparator
description: Late disclosure group receives results of genetic testing at final study visit (Month 12)
intervention type: Behavioral
intervention name: Early disclosure
arm group label: Early disclosure
intervention type: Behavioral
intervention name: Late disclosure
arm group label: Late disclosure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul S. Bernstein, MD, PhD
role: Principal Investigator
affiliation: University of Utah Moran Eye Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Paul S. Bernstein
investigator title: Professor, Ophthalmology/Visual Sciences
mesh term: Macular Degeneration
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic
sharing ipd: No