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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04423718 | Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye | PHASE3 | COMPLETED | 1,011 | — | — | Aug 11, 2020 | Aug 7, 2024 | Aug 29, 2025 | 235 | United States, Argentina +25 |
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
| Arm | Type | Description |
|---|---|---|
| Aflibercept 2q8 | ACTIVE_COMPARATOR | In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental) |
| Aflibercept HDq12 | EXPERIMENTAL | Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. |
| Aflibercept HDq16 | EXPERIMENTAL | Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. |
| Name | Type | Description |
|---|---|---|
| Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) | DRUG | Solution in Vial, intravitreal (IVT) injection |
| Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) | DRUG | Solution in Vial, 2 mg, intravitreal (IVT) injection |
Inclusion Criteria: * Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye. * Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye. * BCVA ETDRS l...