<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/NCT03242083</url>
  </required_header>
  <id_info>
    <org_study_id>KAUFFMANN PCA 2016</org_study_id>
    <nct_id>NCT03242083</nct_id>
  </id_info>
  <brief_title>Evaluate the Quality of Life of Patients With AMD</brief_title>
  <acronym>QUASAR</acronym>
  <official_title>Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because&#xD;
      of progressive deterioration of the macula, patients with AMD complain about progressive&#xD;
      visual problems that can impair their quality of life in the physical, mental and social&#xD;
      domains. The principal objective principal of this study is to describe the evolution of&#xD;
      quality of life between the diagnosis of secondary atrophic AMD and at 18 months after&#xD;
      confirmation of diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</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>responses to a quality of life questionnaire</measure>
    <time_frame>Change compared with baseline score at month 6, month 12 and month 18</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Primary atrophic AMD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary atrophic AMD</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality of life questionnaire</intervention_name>
    <description>quality of life questionnaire</description>
    <arm_group_label>Primary atrophic AMD</arm_group_label>
    <arm_group_label>Secondary atrophic AMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        During an ophthalmology consultation, the clinician who has established the diagnosis of&#xD;
        primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient&#xD;
        fulfilling the aforementioned eligibility criteria to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - For the 2 populations studied&#xD;
&#xD;
          -  Persons who have given consent to take part&#xD;
&#xD;
          -  Persons aged 50 years or older&#xD;
&#xD;
          -  Willing and able to attend all of the scheduled visits and evaluations&#xD;
&#xD;
          -  Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at&#xD;
             least 63μm&#xD;
&#xD;
          -  Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2&#xD;
             independent experienced assessors&#xD;
&#xD;
          -  Diagnosed for less than 3 years&#xD;
&#xD;
          -  MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial&#xD;
             distance of 4m&#xD;
&#xD;
        For patients with secondary atrophic AMD&#xD;
&#xD;
        • Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last&#xD;
        injection of an anti-angiogenic agent, and at least 2 years after the first injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General criteria&#xD;
&#xD;
          -  Persons without national health insurance cover&#xD;
&#xD;
          -  Physical or mental disability ruling out participation&#xD;
&#xD;
          -  Inability to sign the written consent form, adults under guardianship&#xD;
&#xD;
          -  Any participation in a study involving an experimental drug during the previous 3&#xD;
             months (dietary supplements are authorised).&#xD;
&#xD;
          -  Adults under guardianship&#xD;
&#xD;
        General medical history&#xD;
&#xD;
        • Uncontrolled AHT&#xD;
&#xD;
        Ophthalmological history&#xD;
&#xD;
          -  Severe non-proliferative or proliferative diabetic retinopathy&#xD;
&#xD;
          -  Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite&#xD;
             treatment with an anti-glaucoma agent) or a history of filtration surgery&#xD;
&#xD;
          -  Corneal disease that could impair vision&#xD;
&#xD;
          -  Monogenic macular dystrophy or toxic maculopathy&#xD;
&#xD;
          -  History of uveitis&#xD;
&#xD;
          -  Amblyopia of the eye concerned&#xD;
&#xD;
          -  Intraocular surgery in the 3 months preceding inclusion&#xD;
&#xD;
          -  History of cornea transplantation in the studied eye&#xD;
&#xD;
          -  Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine,&#xD;
             tamoxifen, interferon (93), external radiotherapy of the face and neck&#xD;
&#xD;
        Ophthalmological examination&#xD;
&#xD;
          -  Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)&#xD;
&#xD;
          -  Active infection in either eye&#xD;
&#xD;
          -  Central anterior serous or active retinopathy in either eye&#xD;
&#xD;
          -  Choroid neo-vascularisation&#xD;
&#xD;
          -  Active serous retinal detachment&#xD;
&#xD;
          -  Refractive error less than -15D or more than +10D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03242083
org study id: KAUFFMANN PCA 2016
nct id: NCT03242083
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because
      of progressive deterioration of the macula, patients with AMD complain about progressive
      visual problems that can impair their quality of life in the physical, mental and social
      domains. The principal objective principal of this study is to describe the evolution of
      quality of life between the diagnosis of secondary atrophic AMD and at 18 months after
      confirmation of diagnosis.
observational model: Cohort
time perspective: Prospective
measure: responses to a quality of life questionnaire
time frame: Change compared with baseline score at month 6, month 12 and month 18
arm group label: Primary atrophic AMD
arm group label: Secondary atrophic AMD
intervention type: Other
intervention name: quality of life questionnaire
description: quality of life questionnaire
arm group label: Primary atrophic AMD
arm group label: Secondary atrophic AMD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Macular Degeneration