Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease

NCT ID: NCT05986786

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2025-03-21

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)

Conditions

Chorioretinal Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVT06 (proposed aflibercept biosimilar) PFS

IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection

Interventions

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

Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alvotech Swiss AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Juergen Agostini

Role: PRINCIPAL_INVESTIGATOR

University Clinic Freiburg

Locations

4001

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

AVT06-GL-D01

Identifier Type: -

Identifier Source: org_study_id