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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505225-13-00
Acronym
AVT06-GL-D01
Enrollment
23
Registered
2023-11-06
Start date
2024-03-11
Completion date
2025-03-18
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chorioretinal vascular disease (neovascular age-related macular degeneration [nAMD], diabetic macular edema [DME], myopic choroidal neovascularization [CNV], retinal vein occlusion [RVO] and diabetic retinopathy [DR])

Brief summary

1. Proportion of AVT06 injections successfully administered with PFS at Day 1. 2. Incidence of ocular TEAEs, AESIs, and SAEs associated with the study eye from Baseline to Week 4.

Interventions

DRUGAflibercept

Sponsors

Alvotech Swiss AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Proportion of AVT06 injections successfully administered with PFS at Day 1. 2. Incidence of ocular TEAEs, AESIs, and SAEs associated with the study eye from Baseline to Week 4.

Countries

Latvia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026