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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Chorioretinal Vascular Disease

Intervention / Treatment
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* Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVT06 (proposed aflibercept biosimilar) PFS<br>IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06 | Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule<br>* Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Week 4 |