<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/NCT01694914</url>
  </required_header>
  <id_info>
    <org_study_id>0908018</org_study_id>
    <secondary_id>2010-A00234-35</secondary_id>
    <nct_id>NCT01694914</nct_id>
  </id_info>
  <brief_title>Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium</brief_title>
  <official_title>Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, all commercially available corneal organ culture media contain foetal calf serum&#xD;
      (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for&#xD;
      corneal cell survival but are problematic because they theoretically have risk of&#xD;
      anthropozoonosis transmission, especially for new variant of CJD and the variability between&#xD;
      FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo&#xD;
      validation of a new medium free compound animal. We proved its superiority over conventional&#xD;
      medium containing 2% FCS for endothelial cell survival during the storage time. The goal of&#xD;
      this clinical trial is now to assess its superiority in patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the primary outcome is the endothelial cell density (ECD) of the corneal grafts.</measure>
    <time_frame>one year after graft</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Corneal Transplantation</condition>
  <arm_group>
    <arm_group_label>Animal Compound Free Medium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>organ culture medium containing 2% of fœtal calf serum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>corneal graft</intervention_name>
    <arm_group_label>Animal Compound Free Medium</arm_group_label>
    <arm_group_label>organ culture medium containing 2% of fœtal calf serum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
          -  Clinically proven corneal disease&#xD;
&#xD;
          -  Registered on the French National waiting list (GLAC)&#xD;
&#xD;
          -  Patient informed consent&#xD;
&#xD;
          -  Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or&#xD;
             combined with lens surgery&#xD;
&#xD;
          -  Low immune rejection risk (&lt; 2 quadrants of neovascularization, no previous history of&#xD;
             herpetic keratitis nor graft rejection)&#xD;
&#xD;
          -  No previous history of glaucoma or elevated intra ocular pressure (&gt;22 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unlikely to comply with the requirements of the protocol&#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>Gilles Thuret, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Besançon</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>January 29, 2015</last_update_submitted>
  <last_update_submitted_qc>January 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corneal Transplantation</keyword>
  <keyword>corneal organ culture medium</keyword>
  <keyword>free animal compound medium</keyword>
  <!-- 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/NCT01694914
org study id: 0908018
secondary id: 2010-A00234-35
nct id: NCT01694914
lead sponsor: 
collaborator: 
has dmc: No
At present, all commercially available corneal organ culture media contain foetal calf serum
      (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for
      corneal cell survival but are problematic because they theoretically have risk of
      anthropozoonosis transmission, especially for new variant of CJD and the variability between
      FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo
      validation of a new medium free compound animal. We proved its superiority over conventional
      medium containing 2% FCS for endothelial cell survival during the storage time. The goal of
      this clinical trial is now to assess its superiority in patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
time frame: one year after graft
arm group label: Animal Compound Free Medium
arm group type: Experimental
description: Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium
arm group label: organ culture medium containing 2% of fœtal calf serum
arm group type: Active Comparator
description: Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum
intervention type: Procedure
intervention name: corneal graft
arm group label: Animal Compound Free Medium
arm group label: organ culture medium containing 2% of fœtal calf serum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Thuret, MD-PhD
role: Principal Investigator
affiliation: CHU Saint-Etienne
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor