Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
Phase 3
Completed
- Conditions
- Chorioretinal Vascular Disease
- Interventions
- Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
- Registration Number
- NCT05986786
- Lead Sponsor
- Alvotech Swiss AG
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVT06 (proposed aflibercept biosimilar) PFS Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
4001
🇬🇪Tbilisi, Georgia