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/NCT05989126</url>
    </required_header>
    <id_info>
      <org_study_id>VGFTe-HD-OD-22105</org_study_id>
      <nct_id>NCT05989126</nct_id>
    </id_info>
    <brief_title>Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)</brief_title>
    <official_title>A Study in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration to Evaluate a High Dose Aflibercept (8 mg) 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>
        Regeneron Pharmaceuticals developed a single-dose glass pre-filled syringe (PFS) to deliver 8&#xD;
        mg aflibercept. The PFS is a convenient device that contains the study medication that will&#xD;
        be injected in your study eye. A PFS offers a sterile, single dose of study drug within the&#xD;
        syringe; this eliminates the need for the retina specialist to prepare the injection syringe&#xD;
        from a separate vial.&#xD;
  &#xD;
        This Phase IIIb study is focused on patients with diabetic macular edema (DME) and&#xD;
        neovascular (wet) age-related macular degeneration (nAMD).&#xD;
  &#xD;
        The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful&#xD;
        preparation and administration of 8 mg aflibercept by retina specialists. The study will also&#xD;
        assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the&#xD;
        study to better understand if the PFS can be used safely and effectively by retina&#xD;
        specialists to administer 8 mg aflibercept.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 13, 2023</start_date>
    <completion_date type="Anticipated">January 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 17, 2024</primary_completion_date>
    <phase>Phase 3</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 8 mg aflibercept injections successfully administered utilizing the 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 adverse events (AEs) in the study eye</measure>
      <time_frame>Through Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of ocular severe adverse events (SAEs) in the study eye</measure>
      <time_frame>Through Day 29</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Diabetic Macular Edema (DME)</condition>
    <condition>Neovascular Age-Related Macular Degeneration (nAMD)</condition>
    <arm_group>
      <arm_group_label>8 mg Dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>aflibercept 8 mg PFS</intervention_name>
      <description>Sterile aqueous solution in a single-dose glass PFS administered by intravitreal (IVT) injection</description>
      <arm_group_label>8 mg Dose</arm_group_label>
      <other_name>EYLEA ®</other_name>
      <other_name>BAY86-5321</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Patient must have diabetic macular edema (DME) or neovascular &quot;wet&quot; age-related&#xD;
               macular degeneration (nAMD) in the study eye&#xD;
  &#xD;
            2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg&#xD;
               aflibercept&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Any active intraocular inflammation or infection in either eye or history of&#xD;
               intraocular inflammation or infection after past IVT injections with any agent in&#xD;
               either eye&#xD;
  &#xD;
            2. Treatment with any IVT injection in the study eye within the 25 days prior to day 1&#xD;
  &#xD;
            3. Intraocular pressure (IOP) &gt;25 mm Hg in the study eye at screening&#xD;
  &#xD;
            4. Any intraocular surgery in the study eye at any time during the past 3 months&#xD;
  &#xD;
            5. Any prior extended-release therapeutic agent, or ocular drug-release device&#xD;
               implantation (approved or investigational, including steroids) in the study eye&#xD;
  &#xD;
          NOTE: Other protocol Defined Inclusion/Exclusion Criteria 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>
    <overall_contact>
      <last_name>Clinical Trials Administrator</last_name>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neovascular &quot;wet&quot; age-related macular degeneration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Degeneration</mesh_term>
      <mesh_term>Macular Edema</mesh_term>
      <mesh_term>Wet Macular Degeneration</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aflibercept</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf</ipd_access_criteria>
      <ipd_url>https://vivli.org/</ipd_url>
    </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/NCT05989126
  org study id: VGFTe-HD-OD-22105
  nct id: NCT05989126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Regeneron Pharmaceuticals developed a single-dose glass pre-filled syringe (PFS) to deliver 8
        mg aflibercept. The PFS is a convenient device that contains the study medication that will
        be injected in your study eye. A PFS offers a sterile, single dose of study drug within the
        syringe; this eliminates the need for the retina specialist to prepare the injection syringe
        from a separate vial.
  
        This Phase IIIb study is focused on patients with diabetic macular edema (DME) and
        neovascular (wet) age-related macular degeneration (nAMD).
  
        The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful
        preparation and administration of 8 mg aflibercept by retina specialists. The study will also
        assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the
        study to better understand if the PFS can be used safely and effectively by retina
        specialists to administer 8 mg aflibercept.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of 8 mg aflibercept injections successfully administered utilizing the 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 adverse events (AEs) in the study eye
  time frame: Through Day 29
  measure: Incidence of ocular severe adverse events (SAEs) in the study eye
  time frame: Through Day 29
  arm group label: 8 mg Dose
  arm group type: Experimental
  description: Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS.
  intervention type: Drug
  intervention name: aflibercept 8 mg PFS
  description: Sterile aqueous solution in a single-dose glass PFS administered by intravitreal (IVT) injection
  arm group label: 8 mg Dose
  other name: EYLEA ®
  other name: BAY86-5321
  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
  last name: Clinical Trials Administrator
  phone: 844-734-6643
  email: clinicaltrials@regeneron.com
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  mesh term: Macular Edema
  mesh term: Wet Macular Degeneration
  mesh term: Aflibercept
  sharing ipd: Yes
  ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
  ipd access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
  ipd url: https://vivli.org/