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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVT06 (proposed aflibercept biosimilar) PFS | Experimental | IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule | Device | Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection |
| 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 |
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Inclusion Criteria :
Exclusion Criteria (selected):
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| Name | Affiliation | Role |
|---|---|---|
| Hans-Juergen Agostini | University Clinic Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4001 | Tbilisi | Georgia |
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