<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/NCT03035461</url>
  </required_header>
  <id_info>
    <org_study_id>PANDA</org_study_id>
    <nct_id>NCT03035461</nct_id>
  </id_info>
  <brief_title>Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration</brief_title>
  <acronym>PANDA</acronym>
  <official_title>Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly&#xD;
      population of the industrialized world. AMD is a progressive degenerative disease affecting&#xD;
      the central area of the retina, responsible for distinct vision. Vision loss arises from&#xD;
      aberrant new vessel growth which causes the accumulation of blood or fluid within the&#xD;
      retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are&#xD;
      exudative, or neovascular or &quot;wet&quot;, and non-exudative, or &quot;dry&quot;.&#xD;
&#xD;
      Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic&#xD;
      process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat&#xD;
      wet-AMD.&#xD;
&#xD;
      After diagnosis and explanations of the practionner, the patients and their close relatives&#xD;
      have still frequently many questions about the intravitreal injections, the prognosis, the&#xD;
      risk of visual impairment, etc. Few teams have studied the modalities of diagnosis&#xD;
      announcement and the understanding of the patients on the disease course.&#xD;
&#xD;
      The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as&#xD;
      well as the understanding of the possibilities of treatment and the clinical surveillance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">October 19, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Description of the patient's feelings</measure>
    <time_frame>up to 1 month after diagnosis</time_frame>
    <description>A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>score of general satisfaction</measure>
    <time_frame>up to 1 month after diagnosis</time_frame>
    <description>the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score on a comprehension quiz on AMD</measure>
    <time_frame>up to 1 month after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on a composite score evaluating the clarity of medical explanations</measure>
    <time_frame>up to 1 month after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on a composite score evaluating the clarity of medical explanations</measure>
    <time_frame>between 6 months and 1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score of satisfaction of announcement conditions</measure>
    <time_frame>up to 1 month after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score of satisfaction of announcement conditions</measure>
    <time_frame>between 6 months and 1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score of satisfactions regarding the clarity of the disease course and treatment explanations</measure>
    <time_frame>between 6 months and 1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the anxiety PHQ9 questionnaire</measure>
    <time_frame>between 6 months and 1 year of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the anxiety GAD7 questionnaire</measure>
    <time_frame>between 6 months and 1 year of follow-up</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI&#xD;
        creteil&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient up to 55 years old&#xD;
&#xD;
          -  wet AMD&#xD;
&#xD;
          -  diagnostic questionnaire group: patient being announced with AMD for less than 1 month&#xD;
&#xD;
          -  disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dry AMD&#xD;
&#xD;
          -  patient under 55 years old&#xD;
&#xD;
          -  patient who doesn't speak French&#xD;
&#xD;
          -  patient carrying an ophtalmologic genetic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marciano Joelle</name>
      <address>
        <city>Créteil</city>
        <state>Creteil</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Intercommunal Creteil</investigator_affiliation>
    <investigator_full_name>Joëlle Marciano</investigator_full_name>
    <investigator_title>Orthoptist in the ophtalmologic department of the CHI Creteil</investigator_title>
  </responsible_party>
  <keyword>diagnosis annoucement</keyword>
  <keyword>patient's feelings</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</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/NCT03035461
org study id: PANDA
nct id: NCT03035461
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly
      population of the industrialized world. AMD is a progressive degenerative disease affecting
      the central area of the retina, responsible for distinct vision. Vision loss arises from
      aberrant new vessel growth which causes the accumulation of blood or fluid within the
      retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are
      exudative, or neovascular or "wet", and non-exudative, or "dry".

      Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic
      process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat
      wet-AMD.

      After diagnosis and explanations of the practionner, the patients and their close relatives
      have still frequently many questions about the intravitreal injections, the prognosis, the
      risk of visual impairment, etc. Few teams have studied the modalities of diagnosis
      announcement and the understanding of the patients on the disease course.

      The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as
      well as the understanding of the possibilities of treatment and the clinical surveillance.
observational model: Cohort
time perspective: Prospective
measure: Description of the patient's feelings
time frame: up to 1 month after diagnosis
description: A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.
measure: score of general satisfaction
time frame: up to 1 month after diagnosis
description: the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
measure: score on a comprehension quiz on AMD
time frame: up to 1 month after diagnosis
measure: Score on a composite score evaluating the clarity of medical explanations
time frame: up to 1 month after diagnosis
measure: Score on a composite score evaluating the clarity of medical explanations
time frame: between 6 months and 1 year of follow-up
measure: score of satisfaction of announcement conditions
time frame: up to 1 month after diagnosis
measure: score of satisfaction of announcement conditions
time frame: between 6 months and 1 year of follow-up
measure: score of satisfactions regarding the clarity of the disease course and treatment explanations
time frame: between 6 months and 1 year of follow-up
measure: Score on the anxiety PHQ9 questionnaire
time frame: between 6 months and 1 year of follow-up
measure: Score on the anxiety GAD7 questionnaire
time frame: between 6 months and 1 year of follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Intercommunal Creteil
investigator full name: Joëlle Marciano
investigator title: Orthoptist in the ophtalmologic department of the CHI Creteil
mesh term: Macular Degeneration
sharing ipd: No