<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/NCT04499820</url>
  </required_header>
  <id_info>
    <org_study_id>OMEDIA</org_study_id>
    <nct_id>NCT04499820</nct_id>
  </id_info>
  <brief_title>Effect of OMEGA3 Supplementation in Diabetic Retinopathy</brief_title>
  <acronym>OMEDIA</acronym>
  <official_title>Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoires Thea</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      The main objective of this study is to evaluate the efficacy at 6 months of omega 3&#xD;
      supplementation on macular capillary density measured in optical coherence tomography&#xD;
      angiography in patients with minimal or moderate non proliferative diabetic retinopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public&#xD;
      health problem.&#xD;
&#xD;
      In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while&#xD;
      diabetic macular edema (DME) affects 5% of them.&#xD;
&#xD;
      Currently, apart from the balance of diabetes and other cardiovascular risk factors, no&#xD;
      specific treatment is given for the minimal and moderate non-proliferative forms.&#xD;
&#xD;
        -  DHA concentration in the retina can be modified according to the patient's diet.&#xD;
&#xD;
        -  Minimal diabetic retinopathy does not currently benefit from specific treatment outside&#xD;
           of diabetic control.&#xD;
&#xD;
        -  Omega 3 are already known for their beneficial effects on the retina, brain and&#xD;
           cardiovascular system but their effectiveness has not been tested on diabetic&#xD;
           retinopathy.&#xD;
&#xD;
        -  It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage&#xD;
           of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.&#xD;
&#xD;
      A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet,&#xD;
      improved the stage of DR in diabetic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">November 25, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 25, 2024</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>density of the deep capillary plexus in optical coherence tomography angiography (OCTA)</measure>
    <time_frame>six months</time_frame>
    <description>Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>capillary plexus density in OCTA</measure>
    <time_frame>six months</time_frame>
    <description>capillary plexus density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area (mm²) of the central avascular zone in OCTA</measure>
    <time_frame>six months</time_frame>
    <description>area (mm²</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity measurement ETDRS</measure>
    <time_frame>six months</time_frame>
    <description>Visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage of diabetic retinopathy: minimal, moderate or severe</measure>
    <time_frame>six months</time_frame>
    <description>Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula.&#xD;
Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages).&#xD;
Moderate nonproliferative DR (by exclusion if neither minimal nor severe DRNP)&#xD;
Severe nonproliferative DR (or preproliferative DR): &quot;4, 2, 1&quot; rule (retinal hemorrhages in 4 quadrants and/or venous dilatations in 2 quadrants and/or AMIR in 1 quadrant)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central retinal thickness (µm) in the 2 groups at 6 months</measure>
    <time_frame>six months</time_frame>
    <description>central retinal thickness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol</measure>
    <time_frame>six months</time_frame>
    <description>cholesterol leve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>triglycerid level</measure>
    <time_frame>six months</time_frame>
    <description>triglycerid level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glycated haemoglobin (percent)</measure>
    <time_frame>six months</time_frame>
    <description>In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method).&#xD;
Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications.&#xD;
9% Very high 7% Recommended 5% Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet questionnaire</measure>
    <time_frame>six months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>NUTROF Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin and DHA supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MERALUT Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrof</intervention_name>
    <description>DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.</description>
    <arm_group_label>NUTROF Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Meralut</intervention_name>
    <description>vitamin A, natural flavonoids, lutein and zeaxanthin</description>
    <arm_group_label>MERALUT Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years&#xD;
&#xD;
          -  For women of childbearing age, an effective method of contraception is introduced and&#xD;
             monitored throughout their participation in the study.&#xD;
&#xD;
          -  Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy&#xD;
             according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.&#xD;
&#xD;
          -  AV &gt; 6/10&#xD;
&#xD;
          -  One eye included. If both are affected, the eye with the poorer perfusion should be&#xD;
             included.&#xD;
&#xD;
          -  Affiliated to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old.&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Other retinal pathologies that may interfere with the results (Patients previously&#xD;
             treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of&#xD;
             glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal&#xD;
             neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema,&#xD;
             macular thickness &gt; 280 µm, Eyes with spherical equivalent greater than 8 Diopters,&#xD;
             OCTA images not interpretable with many artifacts.)&#xD;
&#xD;
          -  Hypersensitivity to any of the components of Nutrof or Meralut&#xD;
&#xD;
          -  Taking the antivitamin k&#xD;
&#xD;
          -  Known deficit in G6PD-&#xD;
&#xD;
          -  History of renal lithiasis&#xD;
&#xD;
          -  Kidney failure&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Chronic Ethylism&#xD;
&#xD;
          -  History of hepatopathy&#xD;
&#xD;
          -  Intracranial tumor, intracranial hypertension&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Patient participating in an intervention study.&#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>Eric SOUIED, MD PhD</last_name>
    <phone>01 45 17 50 00</phone>
    <email>eric.souied@chicreteil.Fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Camille JUNG, MD</last_name>
    <phone>01 45 17 50 00</phone>
    <email>camille.jung@chicreteil.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHI Creteil</name>
      <address>
        <city>Créteil</city>
        <state>Creteil</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric SOUIED, MDH</last_name>
      <phone>01 45 17 52 22</phone>
      <phone_ext>33</phone_ext>
      <email>eric.souied@chicreteil.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 3, 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>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</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>
  <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/NCT04499820
org study id: OMEDIA
nct id: NCT04499820
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to evaluate the efficacy at 6 months of omega 3
      supplementation on macular capillary density measured in optical coherence tomography
      angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public
      health problem.

      In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while
      diabetic macular edema (DME) affects 5% of them.

      Currently, apart from the balance of diabetes and other cardiovascular risk factors, no
      specific treatment is given for the minimal and moderate non-proliferative forms.

        -  DHA concentration in the retina can be modified according to the patient's diet.

        -  Minimal diabetic retinopathy does not currently benefit from specific treatment outside
           of diabetic control.

        -  Omega 3 are already known for their beneficial effects on the retina, brain and
           cardiovascular system but their effectiveness has not been tested on diabetic
           retinopathy.

        -  It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage
           of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.

      A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet,
      improved the stage of DR in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
time frame: six months
description: Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.
measure: capillary plexus density in OCTA
time frame: six months
description: capillary plexus density
measure: area (mm²) of the central avascular zone in OCTA
time frame: six months
description: area (mm²
measure: Visual acuity measurement ETDRS
time frame: six months
description: Visual acuity
measure: Stage of diabetic retinopathy: minimal, moderate or severe
time frame: six months
description: Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula.
Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages).
Moderate nonproliferative DR (by exclusion if neither minimal nor severe DRNP)
Severe nonproliferative DR (or preproliferative DR): "4, 2, 1" rule (retinal hemorrhages in 4 quadrants and/or venous dilatations in 2 quadrants and/or AMIR in 1 quadrant)
measure: central retinal thickness (µm) in the 2 groups at 6 months
time frame: six months
description: central retinal thickness
measure: cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
time frame: six months
description: cholesterol leve
measure: triglycerid level
time frame: six months
description: triglycerid level
measure: glycated haemoglobin (percent)
time frame: six months
description: In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method).
Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications.
9% Very high 7% Recommended 5% Normal
measure: Diet questionnaire
time frame: six months
description: questionnaire
arm group label: NUTROF Group
arm group type: Experimental
description: vitamin and DHA supplementation
arm group label: MERALUT Group
arm group type: Placebo Comparator
description: vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA
intervention type: Dietary Supplement
intervention name: Nutrof
description: DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
arm group label: NUTROF Group
intervention type: Dietary Supplement
intervention name: Meralut
description: vitamin A, natural flavonoids, lutein and zeaxanthin
arm group label: MERALUT Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric SOUIED, MD PhD
phone: 01 45 17 50 00
email: eric.souied@chicreteil.Fr
last name: Camille JUNG, MD
phone: 01 45 17 50 00
email: camille.jung@chicreteil.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: No