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Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (ALVOEYE-D)

Primary Purpose

Chorioretinal Vascular Disease

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
Sponsored by
Alvotech Swiss AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioretinal Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria : Male or female ≥18 years old Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures Willing and able to comply with all study procedures and be likely to complete the study Subjects must be able to follow the contraception requirements Exclusion Criteria (selected): Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AVT06 (proposed aflibercept biosimilar) PFS

    Arm Description

    IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06

    Outcomes

    Primary Outcome Measures

    Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
    Proportion of AVT06 injections successfully administered with PFS at Day 1
    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
    Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 11, 2023
    Sponsor
    Alvotech Swiss AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05986786
    Brief Title
    Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
    Acronym
    ALVOEYE-D
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alvotech Swiss AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chorioretinal Vascular Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AVT06 (proposed aflibercept biosimilar) PFS
    Arm Type
    Experimental
    Arm Description
    IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06
    Intervention Type
    Device
    Intervention Name(s)
    Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
    Intervention Description
    Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
    Primary Outcome Measure Information:
    Title
    Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
    Description
    Proportion of AVT06 injections successfully administered with PFS at Day 1
    Time Frame
    Day 1
    Title
    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
    Description
    Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4
    Time Frame
    Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria : Male or female ≥18 years old Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures Willing and able to comply with all study procedures and be likely to complete the study Subjects must be able to follow the contraception requirements Exclusion Criteria (selected): Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Silvia Cirillo
    Phone
    +41789777056
    Email
    silvia.cirillo@alvotech.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Riken Soni
    Email
    riken.soni@alvotech.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans-Juergen Agostini
    Organizational Affiliation
    University Clinic Freiburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease

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