<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/NCT01716026</url>
  </required_header>
  <id_info>
    <org_study_id>IOBA-04-2012</org_study_id>
    <nct_id>NCT01716026</nct_id>
  </id_info>
  <brief_title>Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia</brief_title>
  <acronym>BENEMCOR</acronym>
  <official_title>Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this protocol is to determine wether the initial protocol in the treatment of&#xD;
      subfoveal choroidal neovascularization associated to High Myopia with bevacizumab&#xD;
      intravitreal injections is more effective when using 3 doses vs using 1 single dose in the&#xD;
      load period&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity</measure>
    <time_frame>1 Year</time_frame>
    <description>Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinal thickness</measure>
    <time_frame>1 Year</time_frame>
    <description>Retinal thickness assessed by Spectral Domain Optical Coherence Tomography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of total injections during study</measure>
    <time_frame>1 Year</time_frame>
    <description>Total count of bevacizumab intravitreal injections during the whole study</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia</condition>
  <arm_group>
    <arm_group_label>3 Month Load with 9 month p.r.n.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Dose Load Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevazizumab intravitreal injection</intervention_name>
    <description>Intravitreal injection of bevacizumab</description>
    <arm_group_label>3 Month Load with 9 month p.r.n.</arm_group_label>
    <arm_group_label>Single Dose Load Phase</arm_group_label>
    <other_name>Avastin Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by&#xD;
             Fundus Fluorescein angiography and Optical Coherence Tomography&#xD;
&#xD;
          -  Best corrected visual acuity loss with less than 6 months of evolution, caused mainly&#xD;
             by the neovascular lesion (based in investigator´s criteria)&#xD;
&#xD;
          -  No atrophy or fibrotic component that may prevent visual acuity improvement&#xD;
&#xD;
          -  Patients previously treated with Photodynamic Therapy are allowed to participate in&#xD;
             this study&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Signed data protection consent&#xD;
&#xD;
          -  Negative pregnancy test in potential childbearing women at screening, with accepted&#xD;
             contraceptive method during the whole study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous vitreous surgery in study eye&#xD;
&#xD;
          -  Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography&#xD;
&#xD;
          -  Media opacities that may prevent correct fundus assessment&#xD;
&#xD;
          -  Lack of posterior capsule integrity in pseudophakic patients&#xD;
&#xD;
          -  Patients with great possibilities of not being able to attend to study visits / follow&#xD;
             visit procedures (investigator´s criteria)&#xD;
&#xD;
          -  Patients previously treated with intravitreal antiangiogenic injections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Maria Ruiz-Moreno, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Castilla-La Mancha</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUS - Fundacion IDICHUS</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>02006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Reina Sofia</name>
      <address>
        <city>Murcia</city>
        <zip>30100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IOBA - Instituto Universitario de Oftalmobiologia Aplicada</name>
      <address>
        <city>Valladolid</city>
        <zip>47011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>high myopia</keyword>
  <keyword>choroidal neovascularization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT01716026
org study id: IOBA-04-2012
nct id: NCT01716026
lead sponsor: 
has dmc: No
The purpose of this protocol is to determine wether the initial protocol in the treatment of
      subfoveal choroidal neovascularization associated to High Myopia with bevacizumab
      intravitreal injections is more effective when using 3 doses vs using 1 single dose in the
      load period
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
time frame: 1 Year
description: Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
measure: Retinal thickness
time frame: 1 Year
description: Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
measure: Number of total injections during study
time frame: 1 Year
description: Total count of bevacizumab intravitreal injections during the whole study
arm group label: 3 Month Load with 9 month p.r.n.
arm group type: Active Comparator
description: 3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit
arm group label: Single Dose Load Phase
arm group type: Experimental
description: Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol
intervention type: Drug
intervention name: Bevazizumab intravitreal injection
description: Intravitreal injection of bevacizumab
arm group label: 3 Month Load with 9 month p.r.n.
arm group label: Single Dose Load Phase
other name: Avastin Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose Maria Ruiz-Moreno, MD PhD
role: Principal Investigator
affiliation: University of Castilla-La Mancha
facility: 
facility: 
facility: 
facility: 
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facility: 
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country: Spain
responsible party type: Sponsor
mesh term: Myopia
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic