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

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)

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)

Study Overview

• Status: Completed
• Conditions: Chorioretinal Vascular Disease
• Intervention / Treatment: Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • 4001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVT06 (proposed aflibercept biosimilar) PFS; IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Alvotech Swiss AG
• Investigators: Principal Investigator: Hans-Juergen Agostini, University clinic Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: AVT06-GL-D01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No