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

NCT05986786 | Completed Phase 3

• 1 other identifier: AVT06-GL-D01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AVT06 (proposed aflibercept biosimilar) PFS

EXPERIMENTAL

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

Interventions

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

Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection

AVT06 (proposed aflibercept biosimilar) PFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (1)

4001

Tbilisi, Georgia

Location

Study Officials

• Hans-Juergen Agostini

  University Clinic Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: February 28, 2024
• Primary Completion: April 19, 2024
• Study Completion: March 21, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

GE (1)