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

Sponsor

Alvotech Swiss AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05986786

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Chorioretinal Vascular Disease	Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS. [Day 1]
Proportion of AVT06 injections successfully administered with PFS at 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 [Week 4]
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Alvotech Swiss AG

Investigators

Principal Investigator: Hans-Juergen Agostini, University Clinic Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alvotech Swiss AG

ClinicalTrials.gov Identifier:

NCT05986786

Other Study ID Numbers:

AVT06-GL-D01

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Aug 15, 2023