NCT05986786
Completed
Phase 3
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)
ConditionsChorioretinal Vascular Disease
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chorioretinal Vascular Disease
- Sponsor
- Alvotech Swiss AG
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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
Study Sites (1)
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