<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/NCT03278262</url>
  </required_header>
  <id_info>
    <org_study_id>19473</org_study_id>
    <nct_id>NCT03278262</nct_id>
  </id_info>
  <brief_title>The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting</brief_title>
  <acronym>INSIGHT</acronym>
  <official_title>INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</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 study will assess the mean change in Visual Acuity (VA) (overall and stratified by&#xD;
      baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.&#xD;
&#xD;
      In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related&#xD;
      Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept&#xD;
      in a real-life setting and it will assess the impact of baseline VA on the outcomes of&#xD;
      Aflibercept treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Visual Acuity (VA) (Snellen)</measure>
    <time_frame>at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up</time_frame>
    <description>Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Early Treatment Diabetic Retinopathy Study (ETDRS)</measure>
    <time_frame>at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up</time_frame>
    <description>Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lasbarhetsindex (LIX, Readability Index)</measure>
    <time_frame>at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up</time_frame>
    <description>Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with Gain of vision 5 to 15 letters; &gt; 15 letters; Loss of vision &gt;5 to &lt;15 letters; &gt;15 letters or Stable -5 to +5 letters at the annual time points</measure>
    <time_frame>At year 1 and year 2</time_frame>
    <description>Patients with Gain of vision 5-15 letters, &gt; 15 letters; Loss of vision &gt;5-&lt;15 letters; &gt;15 letters or Stable -5-+5 letters at the annual time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>In all patients and stratified by baseline VA (groups 1-3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>In all patients and stratified by baseline VA (groups 1-3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with no need of Vision Aid support</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2312</enrollment>
  <condition>Wet Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>&gt;= 70 letters</arm_group_label>
    <description>Baseline VA &gt;= 70 letters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>36-69 letters</arm_group_label>
    <description>Baseline VA 36-69 letters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&lt;=35 letters</arm_group_label>
    <description>Baseline VA &lt;=35 letters</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept (Eylea, BAY86-5321)</intervention_name>
    <description>Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.</description>
    <arm_group_label>36-69 letters</arm_group_label>
    <arm_group_label>&lt;=35 letters</arm_group_label>
    <arm_group_label>&gt;= 70 letters</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients registered in the Swedish Macula Register during the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment-naïve eyes with neovascularization AMD, with the indication to be treated&#xD;
             with Aflibercept. One and/or two eyes per patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eyes treated previously with another anti-VEGF drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products.</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</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>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_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/NCT03278262
org study id: 19473
nct id: NCT03278262
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will assess the mean change in Visual Acuity (VA) (overall and stratified by
      baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.

      In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related
      Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept
      in a real-life setting and it will assess the impact of baseline VA on the outcomes of
      Aflibercept treatment.
observational model: Cohort
time perspective: Retrospective
measure: Change in Visual Acuity (VA) (Snellen)
time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
description: Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.
measure: Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
description: Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.
measure: Change in Lasbarhetsindex (LIX, Readability Index)
time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
description: Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden
measure: Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points
time frame: At year 1 and year 2
description: Patients with Gain of vision 5-15 letters, > 15 letters; Loss of vision >5-<15 letters; >15 letters or Stable -5-+5 letters at the annual time points
measure: Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
time frame: Up to 2 years
description: In all patients and stratified by baseline VA (groups 1-3)
measure: Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
time frame: Up to 2 years
description: In all patients and stratified by baseline VA (groups 1-3)
measure: Proportion of patients with no need of Vision Aid support
time frame: Up to 2 years
arm group label: >= 70 letters
description: Baseline VA >= 70 letters
arm group label: 36-69 letters
description: Baseline VA 36-69 letters
arm group label: <=35 letters
description: Baseline VA <=35 letters
intervention type: Drug
intervention name: Aflibercept (Eylea, BAY86-5321)
description: Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.
arm group label: 36-69 letters
arm group label: <=35 letters
arm group label: >= 70 letters
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products.
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
mesh term: Aflibercept