xml: <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/NCT06041256</url>
    </required_header>
    <id_info>
      <org_study_id>ABA-1</org_study_id>
      <nct_id>NCT06041256</nct_id>
    </id_info>
    <brief_title>A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel- Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)</brief_title>
    <acronym>CLARA</acronym>
    <official_title>CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aurion Biotech</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aurion Biotech</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare different doses of AURN001 in patients with&#xD;
        corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical&#xD;
        trial aims to answer are whether AURN001 effective and safe. Participants will receive a&#xD;
        single injection of AURN001. A comparison between low, medium, and high doses of AURN001&#xD;
        against the contribution of each element, cells alone and Y27632 alone, will be conducted to&#xD;
        determine the effects on corneal edema.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</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>BCVA - 15-letter improvement (3-line gain)</measure>
      <time_frame>Month 6</time_frame>
      <description>Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)</description>
    </primary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Corneal Edema</condition>
    <condition>Corneal Endothelial Dysfunction</condition>
    <arm_group>
      <arm_group_label>AURN001 High</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neltependocel High and Rho-associated protein kinase</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AURN001 Medium</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neltependocel Medium and Rho-associated protein kinase</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AURN001 Low</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neltependocel Low and Rho-associated protein kinase</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Neltependocel - High</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neltependocel - High</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ROCK</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rho-associated protein kinase (ROCK)</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>AURN001</intervention_name>
      <description>Corneal Endothelial Cells and Y27632</description>
      <arm_group_label>AURN001 High</arm_group_label>
      <arm_group_label>AURN001 Low</arm_group_label>
      <arm_group_label>AURN001 Medium</arm_group_label>
      <arm_group_label>Neltependocel - High</arm_group_label>
      <arm_group_label>ROCK</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction,&#xD;
               requiring surgery (full- or partial-thickness endothelial keratoplasty)&#xD;
  &#xD;
            -  BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e.,&#xD;
               0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6&#xD;
               LogMAR or approximate 20/800 Snellen equivalent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other&#xD;
               opacity that is paracentral/central and visually significant, but not suspected to be&#xD;
               secondary to corneal endothelial disease with the potential to improve from treatment&#xD;
               in the study eye&#xD;
  &#xD;
            -  Have history or presence of an ocular disease other than corneal endothelial&#xD;
               dysfunction that could affect vision or safety assessments&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Manager, OD</last_name>
      <role>Study Director</role>
      <affiliation>Aurion Biotech</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Manager, OD</last_name>
      <phone>18576394161</phone>
      <email>clara.study.@aurionbiotech.com</email>
    </overall_contact>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Corneal Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041256
  org study id: ABA-1
  nct id: NCT06041256
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to compare different doses of AURN001 in patients with
        corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical
        trial aims to answer are whether AURN001 effective and safe. Participants will receive a
        single injection of AURN001. A comparison between low, medium, and high doses of AURN001
        against the contribution of each element, cells alone and Y27632 alone, will be conducted to
        determine the effects on corneal edema.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: BCVA - 15-letter improvement (3-line gain)
  time frame: Month 6
  description: Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)
  arm group label: AURN001 High
  arm group type: Experimental
  description: Neltependocel High and Rho-associated protein kinase
  arm group label: AURN001 Medium
  arm group type: Experimental
  description: Neltependocel Medium and Rho-associated protein kinase
  arm group label: AURN001 Low
  arm group type: Experimental
  description: Neltependocel Low and Rho-associated protein kinase
  arm group label: Neltependocel - High
  arm group type: Experimental
  description: Neltependocel - High
  arm group label: ROCK
  arm group type: Experimental
  description: Rho-associated protein kinase (ROCK)
  intervention type: Combination Product
  intervention name: AURN001
  description: Corneal Endothelial Cells and Y27632
  arm group label: AURN001 High
  arm group label: AURN001 Low
  arm group label: AURN001 Medium
  arm group label: Neltependocel - High
  arm group label: ROCK
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Study Manager, OD
  role: Study Director
  affiliation: Aurion Biotech
  last name: Study Manager, OD
  phone: 18576394161
  email: clara.study.@aurionbiotech.com
  responsible party type: Sponsor
  mesh term: Corneal Edema
  mesh term: Edema
  sharing ipd: No