Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (ALVOEYE-D)

Alvotech

Status and phase: Completed; Phase 3

Conditions: Chorioretinal Vascular Disease

Treatments: Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05986786

AVT06-GL-D01

Details and patient eligibility

About

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)

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

AVT06 (proposed aflibercept biosimilar) PFS

Experimental group

Description:

IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06

Treatment:

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