<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/NCT03767738</url>
  </required_header>
  <id_info>
    <org_study_id>VGFTe-OD-1881</org_study_id>
    <nct_id>NCT03767738</nct_id>
  </id_info>
  <brief_title>Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe</brief_title>
  <official_title>A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine if the pre-filled syringe (PFS) supports&#xD;
      successful preparation and accurate administration of an aflibercept injection.&#xD;
&#xD;
      The secondary objective of the study is to assess ocular safety in the study eye.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">August 19, 2020</completion_date>
  <primary_completion_date type="Actual">August 19, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)</measure>
    <time_frame>At Day 1</time_frame>
    <description>Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Ocular Serious TEAEs of Study Eye Through Day 29</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Chorioretinal Vascular Disease</condition>
  <arm_group>
    <arm_group_label>Intravitreal Aflibercept Injection (IAI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1 - Initial patients Cohort 2 - Additional patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravitreal Aflibercept Injection (IAI)</intervention_name>
    <description>IAI prepared and administered with a pre-filled syringe (PFS)</description>
    <arm_group_label>Intravitreal Aflibercept Injection (IAI)</arm_group_label>
    <other_name>Aflibercept</other_name>
    <other_name>EYLEA®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have neovascular age-related macular degeneration (AMD), diabetic&#xD;
             macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with&#xD;
             diabetic macular edema (DME) in the study eye&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in&#xD;
             either eye&#xD;
&#xD;
          -  Any active intraocular inflammation or infection in either eye or history of&#xD;
             intraocular inflammation or infection after past intravitreal injection treatment&#xD;
             (IVT) injections with any agent in either eye&#xD;
&#xD;
          -  History of or any current indication of excessive bleeding and recurrent hemorrhages,&#xD;
             including any prior excessive intraocular (including subconjunctival) bleeding or&#xD;
             hemorrhages after IVT injection or intraocular procedures in either eye&#xD;
&#xD;
          -  Any intraocular surgery in the study eye at any time during the past 3 months&#xD;
&#xD;
          -  Current systemic infectious disease or a therapy for active infectious disease&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
        Note: Other inclusion/ exclusion apply&#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>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>August 18, 2021</results_first_submitted>
  <results_first_submitted_qc>August 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2021</results_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</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>Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03767738/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03767738/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 65 participants were enrolled in the United States.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
          <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: IAI 2 mg</title>
          <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
          <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: IAI 2 mg</title>
          <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.2" spread="10.04"/>
                    <measurement group_id="B2" value="64.7" spread="13.44"/>
                    <measurement group_id="B3" value="68.8" spread="12.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)</title>
        <description>Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.</description>
        <time_frame>At Day 1</time_frame>
        <population>Safety analysis set (SAF) included all enrolled participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
            <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IAI 2 mg</title>
            <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)</title>
          <description>Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.</description>
          <population>Safety analysis set (SAF) included all enrolled participants who received study drug.</population>
          <units>Injections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29</title>
        <description>A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>SAF included all enrolled participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
            <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IAI 2 mg</title>
            <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29</title>
          <description>A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
          <population>SAF included all enrolled participants who received study drug.</population>
          <units>Events</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Conjunctival haemorrhage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eye irritation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dry eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eye pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lenticular opacities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal abrasion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Ocular Serious TEAEs of Study Eye Through Day 29</title>
        <description>A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>SAF included all enrolled participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
            <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IAI 2 mg</title>
            <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Ocular Serious TEAEs of Study Eye Through Day 29</title>
          <description>A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.</description>
          <population>SAF included all enrolled participants who received study drug.</population>
          <units>Events</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 29</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Intravitreal Aflibercept Injection (IAI) 2 mg</title>
          <description>Participants in cohort 1 received a single IAI in a prefilled syringe (PFS) at a dose of 2 milligrams (mg) on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: IAI 2 mg</title>
          <description>Participants in cohort 2 received a single IAI in a PFS at a dose of 2 mg on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage Study Eye</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Eye irritation Study Eye</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Management</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc</organization>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03767738
org study id: VGFTe-OD-1881
nct id: NCT03767738
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports
      successful preparation and accurate administration of an aflibercept injection.

      The secondary objective of the study is to assess ocular safety in the study eye.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
time frame: At Day 1
description: Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
measure: Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
time frame: Baseline through Day 29
description: A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.
measure: Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
time frame: Baseline through Day 29
description: A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.
arm group label: Intravitreal Aflibercept Injection (IAI)
arm group type: Experimental
description: Cohort 1 - Initial patients Cohort 2 - Additional patients
intervention type: Drug
intervention name: Intravitreal Aflibercept Injection (IAI)
description: IAI prepared and administered with a pre-filled syringe (PFS)
arm group label: Intravitreal Aflibercept Injection (IAI)
other name: Aflibercept
other name: EYLEA®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Aflibercept
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 