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/NCT05978622</url>
    </required_header>
    <id_info>
      <org_study_id>P23-380</org_study_id>
      <nct_id>NCT05978622</nct_id>
    </id_info>
    <brief_title>Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant</brief_title>
    <official_title>A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>
        The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the&#xD;
        retina over time. It is an approved drug for the treatment of DME. This study will assess&#xD;
        adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular&#xD;
        endothelial growth factor therapy that are treated with DEX-I in the routine clinical&#xD;
        setting.&#xD;
  &#xD;
        Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled&#xD;
        at approximately 40 sites in approximately 10 countries globally.&#xD;
  &#xD;
        Participants will be followed for 18 months post-DEX-I implantation according to the routine&#xD;
        clinical practice of the prescribing centers. Only one eye per participant will be evaluated&#xD;
        in the study.&#xD;
  &#xD;
        No additional burden for participants in this trial is expected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2026</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>Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation</measure>
      <time_frame>Baseline to 18 Months</time_frame>
      <description>Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">327</enrollment>
    <condition>Diabetic Macular Edema</condition>
    <arm_group>
      <arm_group_label>Dexamethasone Intravitreal Implant (DEX-I)</arm_group_label>
      <description>Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF&#xD;
          therapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant diagnosed with DME in the study eye&#xD;
  &#xD;
            -  Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12&#xD;
               months prior to DEX-I initiation&#xD;
  &#xD;
            -  Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and&#xD;
               reflects their standard practice&#xD;
  &#xD;
            -  Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any concomitant ocular or neurologic condition in the study eye that could cause&#xD;
               macular edema or affect vision (except cataract)&#xD;
  &#xD;
            -  History of ocular surgery within 60 days of Baseline in the study eye&#xD;
  &#xD;
            -  History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the&#xD;
               study eye in the 3 months prior to Baseline&#xD;
  &#xD;
            -  Significant media opacities in the study eye limiting Optical Coherence Tomography&#xD;
               (OCT) quality&#xD;
  &#xD;
            -  Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye&#xD;
  &#xD;
            -  Active ocular inflammation in either eye&#xD;
  &#xD;
            -  Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber&#xD;
               Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of&#xD;
               complicated cataract surgery with PCR&#xD;
  &#xD;
            -  Prior use of intravitreal corticosteroids in the study eye&#xD;
  &#xD;
            -  Patients with contraindications to DEX-I&#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>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrew Shirlaw</last_name>
      <phone>844-663-3742</phone>
      <email>andrew.shirlaw@abbvie.com</email>
    </overall_contact>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=P23-380</url>
      <description>Related Info</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetic Macular Edema</keyword>
    <keyword>DME</keyword>
    <keyword>Dexamethasone</keyword>
    <keyword>Dexamethasone Intravitreal Implant</keyword>
    <keyword>Ozurdex</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05978622
  org study id: P23-380
  nct id: NCT05978622
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the
        retina over time. It is an approved drug for the treatment of DME. This study will assess
        adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular
        endothelial growth factor therapy that are treated with DEX-I in the routine clinical
        setting.
  
        Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled
        at approximately 40 sites in approximately 10 countries globally.
  
        Participants will be followed for 18 months post-DEX-I implantation according to the routine
        clinical practice of the prescribing centers. Only one eye per participant will be evaluated
        in the study.
  
        No additional burden for participants in this trial is expected.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
  time frame: Baseline to 18 Months
  description: Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
  arm group label: Dexamethasone Intravitreal Implant (DEX-I)
  description: Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: Andrew Shirlaw
  phone: 844-663-3742
  email: andrew.shirlaw@abbvie.com
  url: https://www.abbvieclinicaltrials.com/study/?id=P23-380
  description: Related Info
  responsible party type: Sponsor
  mesh term: Macular Edema
  mesh term: Edema
  sharing ipd: Undecided