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/NCT05966753</url>
    </required_header>
    <id_info>
      <org_study_id>1485-0016</org_study_id>
      <nct_id>NCT05966753</nct_id>
    </id_info>
    <brief_title>Describing Patient With DME, Their Patient Journey and Disease Progression</brief_title>
    <official_title>Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</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>
        This study aims to characterize patients with diabetic macular edema (DME), their&#xD;
        progression, the treatment received and associate the functional and physiological outcomes&#xD;
        related to the treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 3, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Change in visual acuity</measure>
      <time_frame>From January 2015 to April 2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression to DME in the fellow eye</measure>
      <time_frame>From January 2015 to April 2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Initial treatment of DME</measure>
      <time_frame>From January 2015 to April 2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Central retinal thickness (CRT)</measure>
      <time_frame>From January 2015 to April 2023</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">182000</enrollment>
    <condition>Diabetic Macular Edema</condition>
    <arm_group>
      <arm_group_label>Patients with Diabetic macular edema cohort</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study population is based on the patients attending a retinal specialist, included in&#xD;
          the Vestrum Retinal specialist database. The study population will include adult patients&#xD;
          with a DME diagnosis in at least one eye.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All patients ≥18 years, with a DME diagnosis in at least one eye, included in the Vestrum&#xD;
          database identified during the study period (January 2015 to April 2023)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients without the information of laterality will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CorEvitas HQ</name>
        <address>
          <city>Waltham</city>
          <state>Massachusetts</state>
          <zip>02451</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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 Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</ipd_description>
    </patient_data>
    <!-- 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/NCT05966753
  org study id: 1485-0016
  nct id: NCT05966753
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to characterize patients with diabetic macular edema (DME), their
        progression, the treatment received and associate the functional and physiological outcomes
        related to the treatment.
  observational model: Cohort
  time perspective: Retrospective
  measure: Change in visual acuity
  time frame: From January 2015 to April 2023
  measure: Progression to DME in the fellow eye
  time frame: From January 2015 to April 2023
  measure: Initial treatment of DME
  time frame: From January 2015 to April 2023
  measure: Central retinal thickness (CRT)
  time frame: From January 2015 to April 2023
  arm group label: Patients with Diabetic macular edema cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  url: http://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Macular Edema
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency