<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/NCT04499157</url>
  </required_header>
  <id_info>
    <org_study_id>PI2019_843_0061</org_study_id>
    <nct_id>NCT04499157</nct_id>
  </id_info>
  <brief_title>Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma</brief_title>
  <acronym>MEMO-GCAO</acronym>
  <official_title>Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric&#xD;
      alterations, and wose only current therapeutic target is the lowering of the intra-ocular&#xD;
      pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline,&#xD;
      magnesium and Gingko biloba, which have a neuroprotective effect already used in&#xD;
      neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown&#xD;
      several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently&#xD;
      in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already&#xD;
      shown results on the preservation of the vision of glaucomatous patients.&#xD;
&#xD;
      The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to&#xD;
      the conventional treatments, in the preservation of vision of patients treated for an&#xD;
      open-angle glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment</measure>
    <time_frame>from day 0 to 2 years</time_frame>
    <description>Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment versus visual field of open angle-glaucoma patients without MEMOPTIC treatment. Visual field is measure with METROVISION Visual Field 24-2, a full field projection perimeter entirely compatible with the Goldmann standard and modern perimetry standard. It allows high resolution static perimetry as well as kinetic perimetry with automated and manual modes. Automated static perimetry is one of the methods used to screen and follow up patients who have glaucoma. It consists of approximately 100 quantitative threshold measures that permit evaluation of retinal sensitivity. Each measure is standardized in a population free of ocular disease, and two simple statistics are calculated: mean deviation (MD) and pattern standard deviation (PSD). These indices are widely used in glaucoma clinical trials and patient follow-up.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Open-angle Glaucoma</condition>
  <condition>Visual Field</condition>
  <arm_group>
    <arm_group_label>MEMOPTIC added to the usual treatment of glaucoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MEMOPTIC added to the usual treatment of glaucoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual treatment of glaucoma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usual treatment of glaucoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEMOPTIC</intervention_name>
    <description>Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following</description>
    <arm_group_label>MEMOPTIC added to the usual treatment of glaucoma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>usual treatment of glaucoma</intervention_name>
    <description>Patients will receive only their usual treatment of glaucoma.</description>
    <arm_group_label>usual treatment of glaucoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects&#xD;
&#xD;
          -  age between 20 and 80 years old&#xD;
&#xD;
          -  Well controled intra-ocular pressure under treatment (PIO&lt;21mmHg or decreased by 20%&#xD;
             compared to initial the PIO)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  retinal or macular disease&#xD;
&#xD;
          -  diagnosis of cataract or surgery of cataract during the follow-up&#xD;
&#xD;
          -  allergy to citicolin&#xD;
&#xD;
          -  ocular hypertonia due to a secondary cause (like corticosteroids)&#xD;
&#xD;
          -  history of anterior, intermediate or posterior uveitis&#xD;
&#xD;
          -  general treatment affecting PIO (beta blockers, corticosteroids)&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Iscar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claire Iscar, MD</last_name>
    <phone>(33)322089200</phone>
    <email>Iscar.claire@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Citicoline</keyword>
  <keyword>Gingko biloba</keyword>
  <keyword>magnesium</keyword>
  <keyword>Open-angle Glaucoma</keyword>
  <keyword>visual field</keyword>
  <keyword>MEMOPTIC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</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/NCT04499157
org study id: PI2019_843_0061
nct id: NCT04499157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric
      alterations, and wose only current therapeutic target is the lowering of the intra-ocular
      pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline,
      magnesium and Gingko biloba, which have a neuroprotective effect already used in
      neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown
      several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently
      in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already
      shown results on the preservation of the vision of glaucomatous patients.

      The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to
      the conventional treatments, in the preservation of vision of patients treated for an
      open-angle glaucoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
time frame: from day 0 to 2 years
description: Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment versus visual field of open angle-glaucoma patients without MEMOPTIC treatment. Visual field is measure with METROVISION Visual Field 24-2, a full field projection perimeter entirely compatible with the Goldmann standard and modern perimetry standard. It allows high resolution static perimetry as well as kinetic perimetry with automated and manual modes. Automated static perimetry is one of the methods used to screen and follow up patients who have glaucoma. It consists of approximately 100 quantitative threshold measures that permit evaluation of retinal sensitivity. Each measure is standardized in a population free of ocular disease, and two simple statistics are calculated: mean deviation (MD) and pattern standard deviation (PSD). These indices are widely used in glaucoma clinical trials and patient follow-up.
arm group label: MEMOPTIC added to the usual treatment of glaucoma
arm group type: Experimental
description: MEMOPTIC added to the usual treatment of glaucoma
arm group label: usual treatment of glaucoma
arm group type: Active Comparator
description: usual treatment of glaucoma
intervention type: Drug
intervention name: MEMOPTIC
description: Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following
arm group label: MEMOPTIC added to the usual treatment of glaucoma
intervention type: Drug
intervention name: usual treatment of glaucoma
description: Patients will receive only their usual treatment of glaucoma.
arm group label: usual treatment of glaucoma
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Claire Iscar, MD
role: Principal Investigator
affiliation: CHU Amiens
last name: Claire Iscar, MD
phone: (33)322089200
email: Iscar.claire@chu-amiens.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No