<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/NCT04485858</url>
  </required_header>
  <id_info>
    <org_study_id>KPro-CIP-001</org_study_id>
    <nct_id>NCT04485858</nct_id>
  </id_info>
  <brief_title>First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness</brief_title>
  <official_title>Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CorNeat Vision Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CorNeat Vision Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and&#xD;
      efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal&#xD;
      blindness&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this clinical study is to prove the safety and effectiveness of the CorNeat&#xD;
      Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal&#xD;
      blindness in subjects who are not candidates for traditional corneal transplant.&#xD;
&#xD;
      Ten subjects who are willing to take part in the study will undergo screening examinations to&#xD;
      verify their eligibility.&#xD;
&#xD;
      The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures&#xD;
      will be performed at 1 day, 1 week, 1, 2, 3, 6, 9 &amp; 12 months post implantation and will&#xD;
      include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular&#xD;
      pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be&#xD;
      assessed and recorded throughout the 12 months follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor's decision&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2021</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Endpoint as determined by the frequency and severity of all unanticipated adverse device-related events (UADE)</measure>
    <time_frame>Throughout the 12 months follow up period</time_frame>
    <description>The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary effectiveness Endpoint - Device retention rate</measure>
    <time_frame>12-months</time_frame>
    <description>Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary effectiveness Endpoint - Improvement in BCDVA</measure>
    <time_frame>12-months</time_frame>
    <description>Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Corneal Disease</condition>
  <condition>Corneal Opacity</condition>
  <condition>Corneal Injuries</condition>
  <arm_group>
    <arm_group_label>CorNeat KPro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraocular implantation of the CorNeat KPro</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CorNeat KPro</intervention_name>
    <description>CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva</description>
    <arm_group_label>CorNeat KPro</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged ≥ 18 and ≤ 80 years on the day of screening&#xD;
&#xD;
          -  Candidates must have the ability and willingness to attend all scheduled visits and&#xD;
             comply with all study procedures&#xD;
&#xD;
          -  Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable&#xD;
             option or following a verifiable history of prior failed corneal transplantation&#xD;
&#xD;
          -  Indications that fall under poor candidate for keratoplasty include but are not&#xD;
             limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial&#xD;
             Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency&#xD;
&#xD;
          -  Pseudophakia&#xD;
&#xD;
          -  Adequate tear film and lid function&#xD;
&#xD;
          -  Perception of light in all quadrants&#xD;
&#xD;
          -  Female patients of childbearing age must have negative pregnancy test at screening and&#xD;
             agree to use an effective method of contraception throughout the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reasonable chance of success with traditional keratoplasty&#xD;
&#xD;
          -  Current retinal detachment&#xD;
&#xD;
          -  Connective tissue diseases&#xD;
&#xD;
          -  End-stage glaucoma&#xD;
&#xD;
          -  History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis,&#xD;
             scleritis) in one or both eyes within 6 months prior to planned implantation&#xD;
&#xD;
          -  History of ocular or periocular malignancy&#xD;
&#xD;
          -  History of extensive keloid formation&#xD;
&#xD;
          -  Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or&#xD;
             component of the device&#xD;
&#xD;
          -  Signs of current infection, including fever and current treatment with antibiotics&#xD;
&#xD;
          -  Severe generalized disease that results in a life expectancy shorter than a year&#xD;
&#xD;
          -  Any clinical evidence that the investigator feels would place the subject at increased&#xD;
             risk with the placement of the device&#xD;
&#xD;
          -  Corneal thickness less than 400 or higher than 1,200 microns in any region of the&#xD;
             pachymetry map of the eye intended to be operated&#xD;
&#xD;
          -  Currently pregnant or breastfeeding&#xD;
&#xD;
          -  Participation in any study involving an investigational drug or device within the past&#xD;
             30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a&#xD;
             study with an investigational drug or device&#xD;
&#xD;
          -  Intraoperative complication that would preclude implantation of the study device&#xD;
&#xD;
          -  Vulnerable populations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 3N9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHN - University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Fondation Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center - Beilinson</name>
      <address>
        <city>Petah tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC - Location AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht UMC+</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Israel</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>September 3, 2023</last_update_submitted>
  <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</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>Blindness</mesh_term>
    <mesh_term>Corneal Injuries</mesh_term>
    <mesh_term>Corneal Diseases</mesh_term>
    <mesh_term>Corneal Opacity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04485858
org study id: KPro-CIP-001
nct id: NCT04485858
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and
      efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal
      blindness
The objective of this clinical study is to prove the safety and effectiveness of the CorNeat
      Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal
      blindness in subjects who are not candidates for traditional corneal transplant.

      Ten subjects who are willing to take part in the study will undergo screening examinations to
      verify their eligibility.

      The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures
      will be performed at 1 day, 1 week, 1, 2, 3, 6, 9 & 12 months post implantation and will
      include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular
      pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be
      assessed and recorded throughout the 12 months follow up period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety Endpoint as determined by the frequency and severity of all unanticipated adverse device-related events (UADE)
time frame: Throughout the 12 months follow up period
description: The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
measure: Primary effectiveness Endpoint - Device retention rate
time frame: 12-months
description: Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit
measure: Secondary effectiveness Endpoint - Improvement in BCDVA
time frame: 12-months
description: Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
arm group label: CorNeat KPro
arm group type: Experimental
description: Intraocular implantation of the CorNeat KPro
intervention type: Device
intervention name: CorNeat KPro
description: CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva
arm group label: CorNeat KPro
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: Israel
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Blindness
mesh term: Corneal Injuries
mesh term: Corneal Diseases
mesh term: Corneal Opacity
sharing ipd: Undecided