Chorioretinal Vascular Disease
Conditions
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)
Interventions
DEVICEPatients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
Sponsors
Alvotech Swiss AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS. | Day 1 | 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 | Week 4 | Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 |
Countries
Georgia
Outcome results
None listed