<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/NCT03813056</url>
  </required_header>
  <id_info>
    <org_study_id>RDMEK-01</org_study_id>
    <nct_id>NCT03813056</nct_id>
  </id_info>
  <brief_title>Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy</brief_title>
  <official_title>A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael D. Straiko, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lions VisionGift Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eye Bank Association of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Legacy Health System</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, published literature has reported that performing a descemetorhexis in combination&#xD;
      with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas&#xD;
      in patients with Fuchs Endothelial Corneal Dystrophy.&#xD;
&#xD;
      Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor,&#xD;
      has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil&#xD;
      acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and&#xD;
      Schlemm's canal.&#xD;
&#xD;
      The goal of this study is to test the potential benefits of Ripasudil therapy administered&#xD;
      after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a&#xD;
      standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs&#xD;
      Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous&#xD;
      corneas faster, with less post-operative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</primary_completion_date>
  <phase>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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to corneal clearance</measure>
    <time_frame>6 months</time_frame>
    <description>Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial cell density</measure>
    <time_frame>6 months</time_frame>
    <description>Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgery complications</measure>
    <time_frame>6 months</time_frame>
    <description>Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Fuchs Endothelial Dystrophy</condition>
  <arm_group>
    <arm_group_label>Glanatec</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glanatec eye drops will be administered 6x per day for 2-4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Optive artificial tears will be administered 6x per day for 2-4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glanatec</intervention_name>
    <description>Rho kinase Inhibitor</description>
    <arm_group_label>Glanatec</arm_group_label>
    <other_name>Ripasudil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Optive, Ophthalmic Solution</intervention_name>
    <description>artificial tears (placebo)</description>
    <arm_group_label>Placebo Control</arm_group_label>
    <other_name>Optive, artificial tears</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Descemet Membrane Endothelial Keratoplasty</intervention_name>
    <description>Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.</description>
    <arm_group_label>Glanatec</arm_group_label>
    <arm_group_label>Placebo Control</arm_group_label>
    <other_name>DMEK</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study&#xD;
             investigator.&#xD;
&#xD;
          -  Phakic or pseudophakic with posterior capsule supported, suture-fixated, or&#xD;
             sulcus-supported posterior chamber intraocular lens.&#xD;
&#xD;
          -  Fuchs dystrophy grades 2-5 on the Krachmer grading scale.&#xD;
&#xD;
          -  Presence of central guttae and/or stromal edema being the primary cause of decreased&#xD;
             vision.&#xD;
&#xD;
          -  The peripheral cornea to the central 6mm is devoid of guttata changes.&#xD;
&#xD;
          -  Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at&#xD;
             study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled glaucoma (IOP &gt;25 mmHg).&#xD;
&#xD;
          -  Presence of secondary corneal pathology such as infective or autoimmune keratitis.&#xD;
&#xD;
          -  Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.&#xD;
&#xD;
          -  History of herpes simplex virus or cytomegalovirus keratitis.&#xD;
&#xD;
          -  Prior penetrating keratoplasty.&#xD;
&#xD;
          -  Aphakic in study eye.&#xD;
&#xD;
          -  Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used&#xD;
             in the course of the study.&#xD;
&#xD;
          -  Tubes or trabeculectomy from prior glaucoma surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D Straiko, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Devers Eye Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alex J Bauer, B.S.</last_name>
    <phone>503-413-8377</phone>
    <email>alex@visiongift.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael D Straiko, M.D.</last_name>
    <phone>503-413-8032</phone>
    <email>mike.straiko@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Devers Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alex J Bauer, B.S.</last_name>
      <phone>503-413-8377</phone>
      <email>alex@visiongift.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Legacy Health System</investigator_affiliation>
    <investigator_full_name>Michael D. Straiko, MD</investigator_full_name>
    <investigator_title>Associate Director of Corneal Services, Devers Eye Institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Lubricant Eye Drops</mesh_term>
  </intervention_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/NCT03813056
org study id: RDMEK-01
nct id: NCT03813056
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
Recently, published literature has reported that performing a descemetorhexis in combination
      with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas
      in patients with Fuchs Endothelial Corneal Dystrophy.

      Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor,
      has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil
      acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and
      Schlemm's canal.

      The goal of this study is to test the potential benefits of Ripasudil therapy administered
      after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a
      standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs
      Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous
      corneas faster, with less post-operative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time to corneal clearance
time frame: 6 months
description: Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
measure: Best corrected visual acuity
time frame: 6 months
description: Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
measure: Endothelial cell density
time frame: 6 months
description: Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
measure: Post surgery complications
time frame: 6 months
description: Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
arm group label: Glanatec
arm group type: Experimental
description: Glanatec eye drops will be administered 6x per day for 2-4 weeks
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Optive artificial tears will be administered 6x per day for 2-4 weeks
intervention type: Drug
intervention name: Glanatec
description: Rho kinase Inhibitor
arm group label: Glanatec
other name: Ripasudil
intervention type: Drug
intervention name: Optive, Ophthalmic Solution
description: artificial tears (placebo)
arm group label: Placebo Control
other name: Optive, artificial tears
intervention type: Procedure
intervention name: Descemet Membrane Endothelial Keratoplasty
description: Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
arm group label: Glanatec
arm group label: Placebo Control
other name: DMEK
criteria: 
gender: All
minimum age: 30 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michael D Straiko, M.D.
role: Principal Investigator
affiliation: Devers Eye Institute
last name: Alex J Bauer, B.S.
phone: 503-413-8377
email: alex@visiongift.org
last name: Michael D Straiko, M.D.
phone: 503-413-8032
email: mike.straiko@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Legacy Health System
investigator full name: Michael D. Straiko, MD
investigator title: Associate Director of Corneal Services, Devers Eye Institute
mesh term: Fuchs' Endothelial Dystrophy
mesh term: Ophthalmic Solutions
mesh term: Lubricant Eye Drops
sharing ipd: No