NCT05986786

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-28
• Primary completion: 2024-04-19
• Completion: 2025-03-21
• First posted: 2023-08-14
• Last updated: 2025-04-22

Locations

1 site across 1 country: Georgia