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

Chorioretinal Vascular Disease Clinical Trial

— ALVOEYE-D  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05986786
• Other study ID #: AVT06-GL-D01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 28, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Alvotech Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: April 2025
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chorioretinal Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Georgia	4001	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Alvotech Swiss AG

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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