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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
4001
Tbilisi, Georgia
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
Time frame: 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
Time frame: Week 4
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