<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/NCT02260687</url>
  </required_header>
  <id_info>
    <org_study_id>17416</org_study_id>
    <secondary_id>EY1414JP</secondary_id>
    <nct_id>NCT02260687</nct_id>
  </id_info>
  <brief_title>Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization</brief_title>
  <official_title>Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to investigate the safety and effectiveness of EYLEA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-interventional, multi center post-authorization safety study that&#xD;
      includes patients with a diagnosis of myopic choroidal neovascularization. The investigator&#xD;
      will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according&#xD;
      the Japanese Package Insert prior to enrolling the patient in this study.&#xD;
&#xD;
      The observation period for each patient starts when therapy with EYLEA is initiated. The&#xD;
      enrollment period is 2 years. Patients will be followed for a time period of 1 years or until&#xD;
      it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients&#xD;
      will be recruited.&#xD;
&#xD;
      For each patient, data are collected as defined in the electronic case report form (eCRF) at&#xD;
      the initial visit, follow-up visits and final visit, either by routine clinical visits (as&#xD;
      per investigators routine practice) .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2014</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">April 2, 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>Number of episodes of Adverse drug reaction (ADR's)</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of episodes of Infections</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of episodes of Serious Adverse Events(SAE's)</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of episodes of Ocular Adverse events</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean changes in visual acuity</measure>
    <time_frame>Baseline up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean changes in retina thickness</measure>
    <time_frame>Baseline up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">353</enrollment>
  <condition>Choroidal Neovascularization</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Decision of treatment is made by attending investigator according to the Japanese Package Insert</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)</intervention_name>
    <description>Administration by intravitreal injection</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female and male patients with mCNV(myopic choroidal neovascularization) diagnosis will be&#xD;
        enrolled after the investigators have taken the decision for the treatment with EYLEA.&#xD;
        Those patients who have had EYLEA prescribed previously will not be included in this study.&#xD;
        Physicians should consult the full prescribing information for EYLEA before enrolling&#xD;
        patients and be familiarized with the safety information in the product package label.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already received EYLEA treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aflibercept</keyword>
  <keyword>Anti-VEGF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT02260687
org study id: 17416
secondary id: EY1414JP
nct id: NCT02260687
lead sponsor: 
collaborator: 
has dmc: No
The objectives of this study are to investigate the safety and effectiveness of EYLEA.
This is a prospective, non-interventional, multi center post-authorization safety study that
      includes patients with a diagnosis of myopic choroidal neovascularization. The investigator
      will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according
      the Japanese Package Insert prior to enrolling the patient in this study.

      The observation period for each patient starts when therapy with EYLEA is initiated. The
      enrollment period is 2 years. Patients will be followed for a time period of 1 years or until
      it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients
      will be recruited.

      For each patient, data are collected as defined in the electronic case report form (eCRF) at
      the initial visit, follow-up visits and final visit, either by routine clinical visits (as
      per investigators routine practice) .
observational model: Cohort
time perspective: Prospective
measure: Number of episodes of Adverse drug reaction (ADR's)
time frame: Up to 12 months
measure: Number of episodes of Infections
time frame: Up to 12 months
measure: Number of episodes of Serious Adverse Events(SAE's)
time frame: Up to 12 months
measure: Number of episodes of Ocular Adverse events
time frame: Up to 12 months
measure: Mean changes in visual acuity
time frame: Baseline up to 12 months
measure: Mean changes in retina thickness
time frame: Baseline up to 12 months
arm group label: Group 1
description: Decision of treatment is made by attending investigator according to the Japanese Package Insert
intervention type: Drug
intervention name: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
description: Administration by intravitreal injection
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Japan
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic
mesh term: Aflibercept