<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/NCT03297515</url>
  </required_header>
  <id_info>
    <org_study_id>TG2017</org_study_id>
    <nct_id>NCT03297515</nct_id>
  </id_info>
  <brief_title>Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease</brief_title>
  <acronym>MADEOS</acronym>
  <official_title>Prospective, Randomised, Double-blind Study to Assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ophthalmos Research and Education Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ophthalmos Research and Education Institute</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3&#xD;
      Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular&#xD;
      Degeneration Omega-3 Study - MADEOS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Age-related macular degeneration (AMD) is the leading cause of blindness in developed&#xD;
      countries. By the year 2040, the number of people suffering from AMD is estimated to increase&#xD;
      by 50%. Stargardt disease is the most prevalent form of macular dystrophy in children, with&#xD;
      an estimated prevalence of 1 in 10000.&#xD;
&#xD;
      There is no effective treatment available that stops progression or improves vision in&#xD;
      patients with dry AMD or Stargardt disease.&#xD;
&#xD;
      Considering the success in animal studies and observational human studies with omega-3 fatty&#xD;
      acids supplementation when the blood ratio AA (arachidonic acid)/EPA (eicosapentaenoic acid)&#xD;
      is &lt;2, the sponsor hypothesizes that, when the blood ratio of AA/EPA is maintained below 2,&#xD;
      the visual acuity in the group with active supplements will improve, in comparison to the&#xD;
      control group, in patients with moderate and severe dry AMD and moderate and severe&#xD;
      Stargardt.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change of letters (BCVA) from screening to 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>Mean change of letters (BCVA) from screening to 24 weeks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Dry AMD</condition>
  <condition>Stargardt Disease 1</condition>
  <arm_group>
    <arm_group_label>Omega 3 fatty acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omega 3 fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (sunflower oil)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Madeos</intervention_name>
    <description>Arm 1: Omega 3</description>
    <arm_group_label>Omega 3 fatty acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Arm 2 : Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ages from 18 to 85 years old.&#xD;
&#xD;
          -  Group 1: For moderate dry macular degeneration the BCVA must be between 50 and 70&#xD;
             (ETDRS) at Screening Visit V1. There must be a large drusen &gt;125 µm within 1mm from&#xD;
             the centre of the fovea. Geographic atrophy can be present but must be &gt;300 µm away&#xD;
             from centre of fovea;&#xD;
&#xD;
          -  Group 2: For severe dry macular degeneration the BCVA must be between 41 and 49&#xD;
             (ETDRS) at Screening Visit V1. Geographic atrophy can involve the fovea but must be&#xD;
             &lt;2500 µm in diameter or any size GA but &gt;200 µm from centre of fovea anywhere;&#xD;
&#xD;
          -  Group 3: For moderate Stargardt disease the BCVA must be between 50 and 70 (ETDRS) at&#xD;
             Screening Visit V1. The geographic area must be &lt;2.0 mm in diameter anywhere;&#xD;
&#xD;
          -  Group 4: For severe Stargardt disease the BCVA must be between 41 and 49 (ETDRS) at&#xD;
             Screening Visit V1. The geographic area must be &lt;2.5 mm in diameter anywhere;&#xD;
&#xD;
          -  Willingness to take the randomised trial investigational product for 6 months;&#xD;
&#xD;
          -  Willingness to consent and undergo the examinations/blood testing at the visits;&#xD;
&#xD;
          -  Be able to swallow large soft gel capsules;&#xD;
&#xD;
          -  Take other supplements as usual; The EPA and DHA intake must be less than 1200 mg/day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any ocular disease in either eye including: Diabetic retinopathy, Central serous&#xD;
             retinopathy, Epiretinal membrane, Optic atrophy, Macular hole or pseudohole, Retinal&#xD;
             vein occlusion, Amblyopia;&#xD;
&#xD;
          -  Previous wet AMD in the study eye;&#xD;
&#xD;
          -  Any previous ocular surgery, which may influence progression of dry macular&#xD;
             degeneration e.g. trabeculectomy, previous refractive surgery, pterygium surgery.&#xD;
             Cataract surgery more than 6 months is not an exclusion criterion unless a&#xD;
             complication has occurred during surgery;&#xD;
&#xD;
          -  Any topical medication administered for other diseases such as glaucoma. Artificial&#xD;
             tears up to 3/day will be allowed;&#xD;
&#xD;
          -  Any ocular condition such as allergic conjunctivitis, moderate to severe dry eyes,&#xD;
             scleritis, uveitis, keratitis, ocular Herpes Simplex keratitis, ectropion, entropion,&#xD;
             ocular surface scaring;&#xD;
&#xD;
          -  Any systemic conditions such as gastrointestinal disease e.g. irritable bowel&#xD;
             syndrome, Crohn's disease, cancer, etc;&#xD;
&#xD;
          -  Any drugs which could affect the eye administered up to 6 months before screening&#xD;
             e.g.: Steroids, Ethambutol, Tamoxifen, Chloroquine, Hydroxychloroquine;&#xD;
&#xD;
          -  Any condition that would not allow follow up e.g. alcoholism or drug abuse;&#xD;
&#xD;
          -  Allergy to any ingredients of the active or placebo pills.&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  Current use of EPA/DHA supplements in excess of 1200 mg/day;&#xD;
&#xD;
          -  History of liver disease;&#xD;
&#xD;
          -  Anti-coagulation therapy such as warfarin/heparin/aspirin/dabigatran/ clopidogrel etc;&#xD;
&#xD;
          -  Bleeding tendencies e.g. coagulopathies;&#xD;
&#xD;
          -  History of atrial fibrillation;&#xD;
&#xD;
          -  Inability to give informed consent (impaired mental capacity e.g. psychiatric&#xD;
             deficit);&#xD;
&#xD;
          -  Smokers or patients who have not been completely smoke free over the past 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre National d'Ophtalmologie des Quinze-Vingts</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Ophthalmology, Justus-Liebig-University-Giessen</name>
      <address>
        <city>Gießen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi G. d'Annunzio Chieti-Pescara</name>
      <address>
        <city>Chieti</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Ophthalmology, University Vita Salute</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Omega-3</keyword>
  <keyword>dry AMD</keyword>
  <keyword>Stargardt</keyword>
  <keyword>visual acuity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Stargardt Disease</mesh_term>
    <mesh_term>Geographic Atrophy</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/NCT03297515
org study id: TG2017
nct id: NCT03297515
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3
      Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular
      Degeneration Omega-3 Study - MADEOS.
Age-related macular degeneration (AMD) is the leading cause of blindness in developed
      countries. By the year 2040, the number of people suffering from AMD is estimated to increase
      by 50%. Stargardt disease is the most prevalent form of macular dystrophy in children, with
      an estimated prevalence of 1 in 10000.

      There is no effective treatment available that stops progression or improves vision in
      patients with dry AMD or Stargardt disease.

      Considering the success in animal studies and observational human studies with omega-3 fatty
      acids supplementation when the blood ratio AA (arachidonic acid)/EPA (eicosapentaenoic acid)
      is <2, the sponsor hypothesizes that, when the blood ratio of AA/EPA is maintained below 2,
      the visual acuity in the group with active supplements will improve, in comparison to the
      control group, in patients with moderate and severe dry AMD and moderate and severe
      Stargardt.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean change of letters (BCVA) from screening to 24 weeks
time frame: 24 weeks
description: Mean change of letters (BCVA) from screening to 24 weeks
arm group label: Omega 3 fatty acids
arm group type: Experimental
description: Omega 3 fatty acids
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (sunflower oil)
intervention type: Dietary Supplement
intervention name: Madeos
description: Arm 1: Omega 3
arm group label: Omega 3 fatty acids
intervention type: Dietary Supplement
intervention name: Placebo
description: Arm 2 : Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Stargardt Disease
mesh term: Geographic Atrophy