Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
4D-150 IVT · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 4D-150 IVT (3E10 vg/eye) | EXPERIMENTAL | - |
| Aflibercept (AFLB) 2 mg IVT | ACTIVE_COMPARATOR | - |
| 4D-150 Part 1 Dose Confirmation Dose Level 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 1 Dose Confirmation Dose Level 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Dose Level 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Dose Level 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Control | ACTIVE_COMPARATOR | Aflibercept at a fixed regimen will be administered. |
| 4D-150 Dose Escalation up to 4 dose levels | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Dose 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Dose 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Control | ACTIVE_COMPARATOR | Aflibercept at a fixed regimen will be administered. |
| 4D-150 Steroid Optimization | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 3 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose |
| 4D-150 Contralateral Eye Dose | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Vector Shedding Dose | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| 4D-150 IVT (3E10 vg/eye) | BIOLOGICAL | If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1 |
| EYLEA® (aflibercept) Injection 2 mg (0.05mL) | BIOLOGICAL | Eylea (aflibercept) will be administered at applicable visits |
| 4D-150 IVT | BIOLOGICAL | 4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept. |
| Aflibercept IVT | BIOLOGICAL | Commercially available Active Comparator |
Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD ...