<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/NCT03812341</url>
  </required_header>
  <id_info>
    <org_study_id>2018-4549</org_study_id>
    <nct_id>NCT03812341</nct_id>
  </id_info>
  <brief_title>SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT</brief_title>
  <official_title>SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is for a &quot;Single Patient Expanded Access&quot; of an on-going study (IRB#2017-3526). In the&#xD;
      on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted&#xD;
      with the KeraKlear device and will be followed for one year. However, this expanded access is&#xD;
      for single patient use below is a description of patient condition and circumstances&#xD;
      necessitating treatment:&#xD;
&#xD;
      88 year old female with 2 previous failed corneal transplants, had significant scarring and&#xD;
      mild edema, surface well epithelialized, has potential for 10 letters of improvement in&#xD;
      visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore&#xD;
      would not be a candidate for standard corneal transplant. She would potentially do well with&#xD;
      a partial thickness artificial cornea such as the KeraKlear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this &quot;Single Patient Expanded Access&quot; the research procedures will be based on the Master&#xD;
      Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under&#xD;
      Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study&#xD;
      visit. This patient is 88 years old as of the submission of this Protocol Narrative to the&#xD;
      IRB.&#xD;
&#xD;
      Postoperatively, subject will be examined at (with window size in parentheses):&#xD;
&#xD;
        -  1 Day (+2 days)&#xD;
&#xD;
        -  1 Week (7±2 days)&#xD;
&#xD;
        -  1 Month (30±5 days)&#xD;
&#xD;
        -  2 Months (60±7 days)&#xD;
&#xD;
        -  3 Months (90±7 days)&#xD;
&#xD;
        -  4 Months (120±10 days)&#xD;
&#xD;
        -  6 Months (180±10 days)&#xD;
&#xD;
        -  9 Months (270±20 days)&#xD;
&#xD;
        -  12 Months (360±20 days)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</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>1.Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ]</measure>
    <time_frame>1 year</time_frame>
    <description>Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental</intervention_name>
    <description>KeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Corneal blindness where cornea transplantation is necessary but is expected to be&#xD;
             unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia&#xD;
             or due to multiple (two or more) failed cornea transplantation surgeries and&#xD;
             spontaneous visual improvement without surgical intervention is not expected or&#xD;
             probable.&#xD;
&#xD;
          -  Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in&#xD;
             the study eye (but at least light perception with projection)&#xD;
&#xD;
          -  Estimated visual potential of the study eye is greater than or equal to at least two&#xD;
             lines visual improvement of BCDVA of current vision in the study eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual Acuity of No Light Perception (NLP) in the study eye&#xD;
&#xD;
          -  The patient is monocular or the non-study eye has Best Corrected Distance Visual&#xD;
             Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe&#xD;
             aniridic limbal stem cell deficiency or due to multiple (two or more) failed cornea&#xD;
             transplantation surgeries.&#xD;
&#xD;
          -  Suitable for standard PK with donor tissue in the study eye.&#xD;
&#xD;
          -  History of severe dry eye syndrome or a Schirmer test with results of less than 3mm&#xD;
             after 5 minutes of testing with the use of topical anesthetic in either eye.&#xD;
&#xD;
          -  Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular&#xD;
             Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis,&#xD;
             etc.).&#xD;
&#xD;
          -  On medications that may affect wound healing, such as antimetabolites or other&#xD;
             chemotherapeutic agents.&#xD;
&#xD;
          -  History of posterior segment eye disease in either eye (including macular&#xD;
             degeneration, optic neuropathy, posterior uveitis) which is expected to limit the&#xD;
             visual improvement to less than two lines of vision.&#xD;
&#xD;
          -  History of retinal surgery in the fellow eye (including retinal detachment repair,&#xD;
             intravitreal injection etc.).&#xD;
&#xD;
          -  History of retinal surgery in the study eye (including retinal detachment repair,&#xD;
             intravitreal injection, etc.) unless the vision is at least light perception with&#xD;
             projection in four field quadrants and the macula is attached (if there is no view of&#xD;
             the retina, an ultrasound must show the macula is attached).&#xD;
&#xD;
          -  History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at&#xD;
             any time in the last 6 months).&#xD;
&#xD;
          -  Current use of beta blocker eye drops (e.g. timolol, levobunolol, etc.).&#xD;
&#xD;
          -  Vertical cup-to-disc (C:D) ratio greater than or equal to 0.8 in either eye (if able&#xD;
             to visible through corneal opacity). If not visible, patient is not to be excluded.&#xD;
&#xD;
          -  Limited visual potential (patient does not have the ability to improve a minimum of&#xD;
             two lines of vision of BCDVA by history).&#xD;
&#xD;
          -  History of amblyopia in the study eye limiting visual potential.&#xD;
&#xD;
          -  If the patient has had a corneal transplant, corneal transplantation surgery was&#xD;
             performed less than 2 years ago.&#xD;
&#xD;
          -  Anticipated need for surgery on the study eye during the course of the study&#xD;
             (including cataract surgery).&#xD;
&#xD;
          -  Aphakia in the study eye.&#xD;
&#xD;
          -  Active ocular infection in either eye.&#xD;
&#xD;
          -  Hypotony in the study eye (IOP &lt; 6mmHg).&#xD;
&#xD;
          -  History of herpetic ocular infection in the study eye.&#xD;
&#xD;
          -  Corneal thickness less than 400 microns in any region of the pachymetry map.&#xD;
&#xD;
          -  Inability to protect the operated eye from trauma.&#xD;
&#xD;
          -  Females who are pregnant, lactating, or unwilling to use adequate birth control for t&#xD;
             the duration of the study.&#xD;
&#xD;
          -  Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the&#xD;
             study.&#xD;
&#xD;
        For this &quot;Single Patient Expanded Access&quot; the research procedures will be based on the&#xD;
        Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page&#xD;
        27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening&#xD;
        study visit. This patient is 88 years old.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>88 year old female.</gender_description>
    <minimum_age>88 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</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>Corneal Opacity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03812341
org study id: 2018-4549
nct id: NCT03812341
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the
      on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted
      with the KeraKlear device and will be followed for one year. However, this expanded access is
      for single patient use below is a description of patient condition and circumstances
      necessitating treatment:

      88 year old female with 2 previous failed corneal transplants, had significant scarring and
      mild edema, surface well epithelialized, has potential for 10 letters of improvement in
      visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore
      would not be a candidate for standard corneal transplant. She would potentially do well with
      a partial thickness artificial cornea such as the KeraKlear.
For this "Single Patient Expanded Access" the research procedures will be based on the Master
      Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under
      Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study
      visit. This patient is 88 years old as of the submission of this Protocol Narrative to the
      IRB.

      Postoperatively, subject will be examined at (with window size in parentheses):

        -  1 Day (+2 days)

        -  1 Week (7±2 days)

        -  1 Month (30±5 days)

        -  2 Months (60±7 days)

        -  3 Months (90±7 days)

        -  4 Months (120±10 days)

        -  6 Months (180±10 days)

        -  9 Months (270±20 days)

        -  12 Months (360±20 days)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1.Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ]
time frame: 1 year
description: Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.
intervention type: Other
intervention name: Experimental
description: KeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity
criteria: 
gender: Female
gender based: Yes
gender description: 88 year old female.
minimum age: 88 Years
maximum age: 88 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Corneal Opacity
sharing ipd: No