Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05155293 | Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) | PHASE3 | COMPLETED | 413 | — | — | Jun 28, 2022 | Sep 23, 2024 | Sep 27, 2024 | 6 | Czechia, Georgia +3 |
| Arm | Type | Description |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | EXPERIMENTAL | Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| Eylea® (Aflibercept) | EXPERIMENTAL | Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| Name | Type | Description |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | DRUG | Patients will receive IVT injections of AVT06 |
| Eylea® (Aflibercept) | DRUG | Patients will receive IVT injections of Eylea® |
Inclusion Criteria: * Subject must be ≥50 years of age, at the time of signing the informed consent. * Subjects must be diagnosed with neovascular (wet) AMD in the study eye. * Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD. * Willingness and ab...