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/NCT05986786</url>
    </required_header>
    <id_info>
      <org_study_id>AVT06-GL-D01</org_study_id>
      <nct_id>NCT05986786</nct_id>
    </id_info>
    <brief_title>Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease</brief_title>
    <acronym>ALVOEYE-D</acronym>
    <official_title>Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Handling and Safety of AVT06 Pre-filled Syringe (PFS) in Subjects With Chorioretinal Vascular Disease Followed by an Optional Extension Phase of AVT06 Pre-filled Syringe (PFS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alvotech Swiss AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alvotech Swiss AG</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 is a single-arm, open label, multicenter clinical study to evaluate the handling and&#xD;
        safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease&#xD;
        followed by an optional extension phase of AVT06 pre-filled syringe (PFS)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 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>Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.</measure>
      <time_frame>Day 1</time_frame>
      <description>Proportion of AVT06 injections successfully administered with PFS at Day 1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS</measure>
      <time_frame>Week 4</time_frame>
      <description>Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Chorioretinal Vascular Disease</condition>
    <arm_group>
      <arm_group_label>AVT06 (proposed aflibercept biosimilar) PFS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule</intervention_name>
      <description>Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection</description>
      <arm_group_label>AVT06 (proposed aflibercept biosimilar) PFS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria :&#xD;
  &#xD;
            -  Male or female ≥18 years old&#xD;
  &#xD;
            -  Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye&#xD;
  &#xD;
            -  Study eye considered by the Principal Investigator to be indicated for treatment with&#xD;
               aflibercept&#xD;
  &#xD;
            -  Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee&#xD;
               (IEC) approved informed consent form (ICF) before any study-specific procedures&#xD;
  &#xD;
            -  Willing and able to comply with all study procedures and be likely to complete the&#xD;
               study&#xD;
  &#xD;
            -  Subjects must be able to follow the contraception requirements&#xD;
  &#xD;
          Exclusion Criteria (selected):&#xD;
  &#xD;
            -  Any concurrent ocular condition in the study eye which, in the opinion of the&#xD;
               Principal Investigator, could either increase the risk to the subject beyond what is&#xD;
               to be expected from standard procedures of IVT injections, or which otherwise may&#xD;
               interfere with the injection procedure or with evaluation of safety&#xD;
  &#xD;
            -  Current systemic infectious disease or a therapy for active infectious disease Any&#xD;
               condition that, in the Principal Investigator's opinion, can interfere with full&#xD;
               participation in the study, including administration of the study treatment and&#xD;
               attending required visits; can pose a significant risk to the subject, or interfere&#xD;
               with interpretation of study data&#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>Hans-Juergen Agostini</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Clinic Freiburg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Silvia Cirillo</last_name>
      <phone>+41789777056</phone>
      <email>silvia.cirillo@alvotech.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Riken Soni</last_name>
      <email>riken.soni@alvotech.com</email>
    </overall_contact_backup>
    <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 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Vascular Diseases</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/NCT05986786
  org study id: AVT06-GL-D01
  nct id: NCT05986786
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-arm, open label, multicenter clinical study to evaluate the handling and
        safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease
        followed by an optional extension phase of AVT06 pre-filled syringe (PFS)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
  time frame: Day 1
  description: Proportion of AVT06 injections successfully administered with PFS at Day 1
  measure: Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS
  time frame: Week 4
  description: Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4
  arm group label: AVT06 (proposed aflibercept biosimilar) PFS
  arm group type: Experimental
  description: IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06
  intervention type: Device
  intervention name: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
  description: Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
  arm group label: AVT06 (proposed aflibercept biosimilar) PFS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hans-Juergen Agostini
  role: Principal Investigator
  affiliation: University Clinic Freiburg
  last name: Silvia Cirillo
  phone: +41789777056
  email: silvia.cirillo@alvotech.com
  last name: Riken Soni
  email: riken.soni@alvotech.com
  responsible party type: Sponsor
  mesh term: Vascular Diseases