<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/NCT03242031</url>
  </required_header>
  <id_info>
    <org_study_id>CREUZOT PRME 2015</org_study_id>
    <nct_id>NCT03242031</nct_id>
  </id_info>
  <brief_title>Medico-economic Comparison Between Treatment With Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy</brief_title>
  <acronym>LIGHT</acronym>
  <official_title>Medico-economic Evaluation of Treatment With Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients With Severe Non-proliferative and Early Proliferative Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the fact that the efficacy of a single session of multispot laser has been&#xD;
      demonstrated in the treatment of patients with diabetic retinopathy as compared with four&#xD;
      sessions of single-spot laser, the management of panretinal photocoagulation in the different&#xD;
      healthcare establishments in France has remained unchanged notably because there is no&#xD;
      specific reimbursement for this new treatment protocol.&#xD;
&#xD;
      Although the benefits of reducing the number of sessions and thus the costs associated with&#xD;
      the treatment for the patient and the payer seem to be obvious, the medico-economic impact of&#xD;
      modifying the treatment strategy thanks to the technological changes must be evaluated to&#xD;
      provide deciders with additional information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cost of treatment</measure>
    <time_frame>9 months after the start of treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>1 session</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4 sessions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>monospot panretinal photocoagulation</intervention_name>
    <description>panretinal photocoagulation with monospot laser</description>
    <arm_group_label>4 sessions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>multispot panretinal photocoagulation</intervention_name>
    <description>panretinal photocoagulation with multispot laser</description>
    <arm_group_label>1 session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons who have provided written informed consent&#xD;
&#xD;
          -  Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic&#xD;
             criteria.&#xD;
&#xD;
          -  Patients with severe non proliferative or early proliferative diabetic retinopathy&#xD;
&#xD;
          -  Visual acuity of the treated eye &gt;= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70&#xD;
             letters Early treatment Diabetic Retinopathy Study)&#xD;
&#xD;
          -  Visual acuity of the contralateral eye &gt;= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35&#xD;
             letters Early treatment Diabetic Retinopathy Study)&#xD;
&#xD;
          -  Patients with a central macular thickness of 350 μm or less on Spectral Domain -&#xD;
             Optical Coherence Tomography&#xD;
&#xD;
          -  Patients with national health insurance cover&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled diabetes in the previous 6 months with intensive insulin therapy&#xD;
             (glycated haemoglobin &gt; 11).&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Florid diabetic retinopathy floride.&#xD;
&#xD;
          -  Macular oedema due to causes other than diabetic retinopathy or in a context of&#xD;
             vitreomacular traction.&#xD;
&#xD;
          -  History of intravitreal treatment with anti-angiogenic agent or corticosteroids within&#xD;
             the 12 previous months.&#xD;
&#xD;
          -  History of treatment with laser in panretinal photocoagulation or focal laser on the&#xD;
             treated eye.&#xD;
&#xD;
          -  History of eye surgery or laser capsulotomy within the previous 6 months&#xD;
&#xD;
          -  History of renal failure requiring dialysis or kidney transplantation for diabetic&#xD;
             nephropathy.&#xD;
&#xD;
          -  Contra-indication for Tropicamide or Neo-synephrine&#xD;
&#xD;
          -  History of uncontrolled glaucoma or hypertonia&#xD;
&#xD;
          -  Patient with aphakia&#xD;
&#xD;
          -  Adult under guardianship&#xD;
&#xD;
          -  Pegnant or breast-feeding women&#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_contact>
    <last_name>Catherine CREUZOT GARCHER, MD</last_name>
    <phone>3.80.29.51.73</phone>
    <phone_ext>+33</phone_ext>
    <email>catherine.creuzot-garcher@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine CREUZOT GARCHER, MD</last_name>
      <phone>3.80.29.51.73</phone>
      <phone_ext>+33</phone_ext>
      <email>catherine.creuzot-garcher@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</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>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</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/NCT03242031
org study id: CREUZOT PRME 2015
nct id: NCT03242031
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Despite the fact that the efficacy of a single session of multispot laser has been
      demonstrated in the treatment of patients with diabetic retinopathy as compared with four
      sessions of single-spot laser, the management of panretinal photocoagulation in the different
      healthcare establishments in France has remained unchanged notably because there is no
      specific reimbursement for this new treatment protocol.

      Although the benefits of reducing the number of sessions and thus the costs associated with
      the treatment for the patient and the payer seem to be obvious, the medico-economic impact of
      modifying the treatment strategy thanks to the technological changes must be evaluated to
      provide deciders with additional information.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cost of treatment
time frame: 9 months after the start of treatment
arm group label: 1 session
arm group type: Experimental
arm group label: 4 sessions
arm group type: Active Comparator
intervention type: Procedure
intervention name: monospot panretinal photocoagulation
description: panretinal photocoagulation with monospot laser
arm group label: 4 sessions
intervention type: Procedure
intervention name: multispot panretinal photocoagulation
description: panretinal photocoagulation with multispot laser
arm group label: 1 session
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine CREUZOT GARCHER, MD
phone: 3.80.29.51.73
phone ext: +33
email: catherine.creuzot-garcher@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy