<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/NCT01732614</url>
  </required_header>
  <id_info>
    <org_study_id>Topcon Endpoint Management</org_study_id>
    <nct_id>NCT01732614</nct_id>
  </id_info>
  <brief_title>Topcon Endpoint Management</brief_title>
  <acronym>Topcon EM</acronym>
  <official_title>Safety Assessment and Therapeutic Effect of Non-damaging Patterned Scanning Laser Phototherapy in Patients With Diffuse Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Retinal Consultants of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Topcon Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Retinal Consultants of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial seeks to prove that sub-lethal laser power levels are as effective and less&#xD;
      damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of&#xD;
      diabetic patients with a disease duration of 20 or more years and is one of the most frequent&#xD;
      causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study&#xD;
      (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of&#xD;
      clinically significant macular edema, reducing the incidence of vision loss by approximately&#xD;
      50% at 3 years' follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in&#xD;
      enhanced expression of heat shock proteins in the retina. To test clinical efficacy of&#xD;
      sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to&#xD;
      establish proper titration methods necessary to assure on one hand the lack of tissue damage,&#xD;
      and on the other hand sufficient hyperthermia to elicit cellular response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Changes in Visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Improvement in visual acuity &gt; 10 letters or two lines in the ETDRS chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of the central macular thickness by SD-OCT</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction of the central macular thickness by SD-OCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cessation of leakage areas on FA</measure>
    <time_frame>12 months</time_frame>
    <description>Use of fluorescein angiography to assess leakage and identify laser burn</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Topcon Endpoint Management Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Topcon Endpoint Management laser</intervention_name>
    <arm_group_label>Topcon Endpoint Management Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have macular edema involving the center of the macula with a&#xD;
             corresponding leakage on fluorescein angiography.&#xD;
&#xD;
          -  Thickening of the fovea of at least 300 microns (thickness of the central point in&#xD;
             OCT) with a standard deviation of the center point &lt;10% and signal strength of ≥ 5 OCT&#xD;
             ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium)&#xD;
             properly identified. Also, the initial OCT must be confirmed by repeated measurements&#xD;
             on the same day, with the thickness of the central point being within 10% between&#xD;
             measurements. In cases where the OCT imaging program can not properly define the&#xD;
             limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of&#xD;
             the manual by OCT central point of at least 300 microns, the patient will be&#xD;
             considered eligible.&#xD;
&#xD;
          -  The distance visual acuity in the better eye corrected the study must have an index&#xD;
             between 70 and 35 letters inclusive (Snellen equivalent of 20/40 to 20/200).&#xD;
&#xD;
          -  Clear media and eye pupil dilation adequate to allow fundus photography with good&#xD;
             quality.&#xD;
&#xD;
          -  Intraocular pressure not exceeding 21 mmHg.&#xD;
&#xD;
          -  The ophthalmologist should feel comfortable with the delay of the focal laser&#xD;
             treatment (direct and grid, as needed) by at least 12 weeks in the study eye.&#xD;
&#xD;
          -  Patients with diabetes Type I or Type II as defined by WHO criteria of any gender and&#xD;
             age ≥ 18 years.&#xD;
&#xD;
          -  Ability to provide a written consent.&#xD;
&#xD;
          -  Ability to return for all study visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where&#xD;
             scatter photocoagulation is required now, or it likely to be needed over the next&#xD;
             6months (for example, eyes with high risk PDR DRS not properly treated with&#xD;
             photocoagulation).&#xD;
&#xD;
          -  Presence of any abnormality that is likely to confound the assessment of the&#xD;
             improvement in visual acuity in eyes with macular edema to resolve or improve as an&#xD;
             area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more&#xD;
             quadrants centered around the foveal avascular zone), epiretinal membrane associated&#xD;
             with signs of contraction and / or significant opacification (ie, striations within&#xD;
             the diameter of a disc from the center of the fovea), or the presence of chorioretinal&#xD;
             atrophy involving the center of the macula.&#xD;
&#xD;
          -  Vitreomacular traction determined clinically and / or OCT, which in the opinion of the&#xD;
             investigator, contributes to macular edema (associated or cause a detachment of the&#xD;
             fovea) and prevents the improvement with treatment.&#xD;
&#xD;
          -  Any cause of macular edema other than DME.&#xD;
&#xD;
          -  Atrophy / scar / fibrosis involving the center of the macula, including evidence of&#xD;
             atrophy treated with laser within 200 microns of the FAZ.&#xD;
&#xD;
          -  Patients who received panphotocoagulation, YAG laser, or peripheral retinal&#xD;
             cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12&#xD;
             weeks or more of treatment with focal or grid laser.&#xD;
&#xD;
          -  Significant opacities of the optical medium, including cataracts, which may interfere&#xD;
             with visual acuity, assessment of toxicity or photography background. Patients will&#xD;
             not be included if they have high probability of requiring cataract surgery within the&#xD;
             next year.&#xD;
&#xD;
          -  Any intraocular surgery within 6 months prior to study entry.&#xD;
&#xD;
          -  Prior peeling of epiretinal membrane or inner limiting membrane.&#xD;
&#xD;
          -  Any major surgical procedure within one month of study entry&#xD;
&#xD;
          -  Prior irradiation of the head region of the eye under study.&#xD;
&#xD;
          -  Any previous pharmacological treatment for DME (including corticosteroid intravitreal,&#xD;
             subconjunctival or subtenon) or at any time during the last 90 days for any other&#xD;
             condition.&#xD;
&#xD;
          -  Important known allergies to sodium fluorescein dye used in angiography.&#xD;
&#xD;
          -  Acute ocular or periocular infection.&#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>Pravin U Dugel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retinal Consultants of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retinal Consultants of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>March 19, 2014</last_update_submitted>
  <last_update_submitted_qc>March 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Macular Edema</keyword>
  <keyword>DME</keyword>
  <keyword>Laser</keyword>
  <keyword>Topcon</keyword>
  <keyword>EndPoint Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <!-- 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/NCT01732614
org study id: Topcon Endpoint Management
nct id: NCT01732614
lead sponsor: 
collaborator: 
has dmc: No
This trial seeks to prove that sub-lethal laser power levels are as effective and less
      damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of
      diabetic patients with a disease duration of 20 or more years and is one of the most frequent
      causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study
      (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of
      clinically significant macular edema, reducing the incidence of vision loss by approximately
      50% at 3 years' follow-up.
Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in
      enhanced expression of heat shock proteins in the retina. To test clinical efficacy of
      sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to
      establish proper titration methods necessary to assure on one hand the lack of tissue damage,
      and on the other hand sufficient hyperthermia to elicit cellular response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Visual acuity
time frame: 12 months
description: Improvement in visual acuity > 10 letters or two lines in the ETDRS chart
measure: Reduction of the central macular thickness by SD-OCT
time frame: 12 months
description: Reduction of the central macular thickness by SD-OCT
measure: Cessation of leakage areas on FA
time frame: 12 months
description: Use of fluorescein angiography to assess leakage and identify laser burn
arm group label: Topcon Endpoint Management Laser
arm group type: Experimental
intervention type: Procedure
intervention name: Topcon Endpoint Management laser
arm group label: Topcon Endpoint Management Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pravin U Dugel, MD
role: Principal Investigator
affiliation: Retinal Consultants of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema