<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/NCT02194803</url>
  </required_header>
  <id_info>
    <org_study_id>CRFB002ADE18</org_study_id>
    <nct_id>NCT02194803</nct_id>
  </id_info>
  <brief_title>Observation of Treatment Patterns With Lucentis in Approved Indications</brief_title>
  <acronym>OCEAN</acronym>
  <official_title>Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicentre, open-label, non-interventional study to observe treatment patterns in patients&#xD;
      with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic&#xD;
      macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to&#xD;
      chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal&#xD;
      injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months&#xD;
      observational period under real life conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2011</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Visual Acuity (VA) to Month 12</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Visual Acuity (VA) to Month 24</measure>
    <time_frame>Baseline, Month 24</time_frame>
    <description>Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5778</enrollment>
  <condition>Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV</condition>
  <arm_group>
    <arm_group_label>Cohort with routine OCT monitoring</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort without routine OCT monitoring</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients suffering from neovascular eye pathology in real life setting for&#xD;
        whom a therapy with Lucentis® is recommended by the treating physician in line with&#xD;
        approved indications. Warnings and contraindications have to be taken into account&#xD;
        according to the summary of product characteristics (SmPC).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Presence of&#xD;
&#xD;
               -  neovascular (wet) age-related macular degeneration (AMD),&#xD;
&#xD;
               -  visual impairment due to diabetic macular oedema (DME),&#xD;
&#xD;
               -  visual impairment due to macular oedema secondary to retinal vein occlusion&#xD;
                  (branch RVO or central RVO) or&#xD;
&#xD;
               -  visual impairment due to choroidal neovascularisation (CNV) secondary to&#xD;
                  pathologic myopia (PM)&#xD;
&#xD;
          -  Patients for whom a therapy with Lucentis® is medically indicated.&#xD;
&#xD;
          -  Written patients informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  As described in the SmPC.&#xD;
&#xD;
          -  Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last&#xD;
             three months before enrollment&#xD;
&#xD;
          -  Preceding intravitreal treatment of the study eye with steroids&#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_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</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>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Macular Edema</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/NCT02194803
org study id: CRFB002ADE18
nct id: NCT02194803
lead sponsor: 
has dmc: No
A multicentre, open-label, non-interventional study to observe treatment patterns in patients
      with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic
      macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to
      chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal
      injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months
      observational period under real life conditions.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Visual Acuity (VA) to Month 12
time frame: Baseline, Month 12
description: Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
measure: Change from Baseline in Visual Acuity (VA) to Month 24
time frame: Baseline, Month 24
description: Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
arm group label: Cohort with routine OCT monitoring
arm group label: Cohort without routine OCT monitoring
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Vision, Low
mesh term: Macular Edema