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NCT Number: NCT05986786

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

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)

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Key information

Conditions

Chorioretinal Vascular Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

4001

Tbilisi, Georgia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.

    Time frame: Day 1

    Proportion of AVT06 injections successfully administered with PFS at Day 1

  2. 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

    Time frame: Week 4

    Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study 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)

Acronym: ALVOEYE-D

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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