xml: <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/NCT06021366</url>
    </required_header>
    <id_info>
      <org_study_id>CRTH258A2015</org_study_id>
      <nct_id>NCT06021366</nct_id>
    </id_info>
    <brief_title>Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study</brief_title>
    <official_title>Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        REALIZE was a single-arm retrospective cohort study which described treatment patterns with&#xD;
        brolucizumab, including treatment intervals between anti-vascular endothelial growth factor&#xD;
        (VEGF) injections before and after a switch to brolucizumab.&#xD;
  &#xD;
        This study was conducted using German patient-level prescription data and the prescription&#xD;
        date was used as a proxy for anti-VEGF injection date.&#xD;
  &#xD;
        The study period was defined from the date of the first available anti-VEGF injection in the&#xD;
        dataset to 30 November 2021. The index date for each patient was the date of the first&#xD;
        brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab&#xD;
        became available in Germany for use outside of clinical trials in March 2020) and 30 November&#xD;
        2021. The date of the patient's first neovascular age-related macular degeneration (nAMD)&#xD;
        diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for&#xD;
        that patient, from January 2015 onwards.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 7, 2022</start_date>
    <completion_date type="Actual">August 29, 2022</completion_date>
    <primary_completion_date type="Actual">August 29, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of brolucizumab injections</measure>
      <time_frame>Up to 12 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 months</measure>
      <time_frame>Up to 12 months</time_frame>
    </secondary_outcome>
    <number_of_groups>8</number_of_groups>
    <enrollment type="Actual">2089</enrollment>
    <condition>Neovascular Age-related Macular Degeneration</condition>
    <arm_group>
      <arm_group_label>12-month follow-up cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-naïve 12-month sub-cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-experienced 12-month sub-cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-experienced, persistent 12-month sub-cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>18-month follow-up cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-naïve 18-month sub-cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-experienced 18-month sub-cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-experienced, persistent 18-month sub-cohort</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Patients aged ≥50 years with a nAMD diagnosis, who received ≥1 brolucizumab prescription&#xD;
          regardless of prior anti-VEGF treatment, and had a minimum of 12-month follow-up from index&#xD;
          date.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients without a record of prescription of any drug in the six months before the&#xD;
               index date (pre-index period).&#xD;
  &#xD;
            -  Patients with evidence of bilateral treatment with brolucizumab.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 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</name>
        <address>
          <city>Porto Salvo</city>
          <zip>2740-255</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>Macular Degeneration</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021366
  org study id: CRTH258A2015
  nct id: NCT06021366
  lead sponsor: 
  REALIZE was a single-arm retrospective cohort study which described treatment patterns with
        brolucizumab, including treatment intervals between anti-vascular endothelial growth factor
        (VEGF) injections before and after a switch to brolucizumab.
  
        This study was conducted using German patient-level prescription data and the prescription
        date was used as a proxy for anti-VEGF injection date.
  
        The study period was defined from the date of the first available anti-VEGF injection in the
        dataset to 30 November 2021. The index date for each patient was the date of the first
        brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab
        became available in Germany for use outside of clinical trials in March 2020) and 30 November
        2021. The date of the patient's first neovascular age-related macular degeneration (nAMD)
        diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for
        that patient, from January 2015 onwards.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of brolucizumab injections
  time frame: Up to 12 months
  measure: Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 months
  time frame: Up to 12 months
  arm group label: 12-month follow-up cohort
  arm group label: Treatment-naïve 12-month sub-cohort
  arm group label: Treatment-experienced 12-month sub-cohort
  arm group label: Treatment-experienced, persistent 12-month sub-cohort
  arm group label: 18-month follow-up cohort
  arm group label: Treatment-naïve 18-month sub-cohort
  arm group label: Treatment-experienced 18-month sub-cohort
  arm group label: Treatment-experienced, persistent 18-month sub-cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: Portugal
  responsible party type: Sponsor
  mesh term: Macular Degeneration