Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (ALVOEYE-D)
Chorioretinal Vascular Disease
About this trial
This is an interventional treatment trial for Chorioretinal Vascular Disease
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
AVT06 (proposed aflibercept biosimilar) PFS
IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06