<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/NCT02264938</url>
  </required_header>
  <id_info>
    <org_study_id>AC-11-112</org_study_id>
    <nct_id>NCT02264938</nct_id>
  </id_info>
  <brief_title>Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation</brief_title>
  <official_title>Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Germans Trias i Pujol Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related&#xD;
      macular degeneration (AMD) after one year of oral supplementation with AREDS-like&#xD;
      formulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study,&#xD;
      and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin&#xD;
      (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg +&#xD;
      eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) +&#xD;
      copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular&#xD;
      pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon&#xD;
      3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed&#xD;
      in all patients, at baseline and 12 months after. Automated delineation of macular drusen was&#xD;
      modified by the investigators when evident segmentation errors occurred.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drusen volume change</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with AREDS category 2 and 3 AMD are observed during 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antioxidant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with AREDS category 2 and 3 AMD are enrolled to take daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg) during 1 year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Antioxidant</intervention_name>
    <description>Oral supplemmentation with antioxidants</description>
    <arm_group_label>Antioxidant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AREDS category 2 and 3 AMD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AREDS category 4 AMD&#xD;
&#xD;
          -  other ophthalmological diseases&#xD;
&#xD;
          -  currently on antioxidant supplementation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Germans Trias i Pujol Hospital</investigator_affiliation>
    <investigator_full_name>Xavier Valldeperas</investigator_full_name>
    <investigator_title>MD, PhD, FEBO</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antioxidants</mesh_term>
  </intervention_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/NCT02264938
org study id: AC-11-112
nct id: NCT02264938
lead sponsor: 
has dmc: No
Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related
      macular degeneration (AMD) after one year of oral supplementation with AREDS-like
      formulation.
Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study,
      and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin
      (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg +
      eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) +
      copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular
      pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon
      3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed
      in all patients, at baseline and 12 months after. Automated delineation of macular drusen was
      modified by the investigators when evident segmentation errors occurred.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Drusen volume change
time frame: 12 months
arm group label: Observation
arm group type: No Intervention
description: Patients with AREDS category 2 and 3 AMD are observed during 1 year
arm group label: Antioxidant
arm group type: Active Comparator
description: Patients with AREDS category 2 and 3 AMD are enrolled to take daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg) during 1 year.
intervention type: Dietary Supplement
intervention name: Antioxidant
description: Oral supplemmentation with antioxidants
arm group label: Antioxidant
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Germans Trias i Pujol Hospital
investigator full name: Xavier Valldeperas
investigator title: MD, PhD, FEBO
mesh term: Macular Degeneration
mesh term: Antioxidants