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Also known as 4D-150 IVT
4D-150 · 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 ...
4D-150 is an investigational ophthalmology therapy being studied for retinal vascular diseases, including neovascular (wet) age-related macular degeneration, macular neovascularization secondary to age-related macular degeneration, and diabetic macular edema. It is also being evaluated in diabetic retinopathy. It is not approved for any use and remains in clinical development.
4D-150 targets VEGF, or vascular endothelial growth factor, a protein that drives abnormal blood vessel growth and leakage in the retina. By targeting VEGF, the therapy aims to address the underlying vascular process in conditions such as neovascular age-related macular degeneration and diabetic macular edema. It is a monoclonal antibody-based modality.
4D-150 is being developed by 4D Molecular Therapeutics, Inc., which trades on the Nasdaq under the ticker FDMT. The company is the sponsor of the clinical program evaluating the therapy across retinal vascular indications, including neovascular age-related macular degeneration and diabetic macular edema.
4D-150 is in Phase 2 development overall, with later-stage activity in neovascular age-related macular degeneration. The program includes Phase 3 studies in macular neovascularization secondary to age-related macular degeneration, a Phase 2 study in diabetic macular edema, and a Phase 1 study in neovascular (wet) age-related macular degeneration. It is investigational and has not been approved by the FDA.
4D-150 is being studied in several registered trials. NCT07064759 is a recruiting Phase 3 study of a single intravitreal injection in macular neovascularization secondary to age-related macular degeneration. NCT06864988 is a Phase 3 study in the same condition that is active but not recruiting. NCT05930561 is a Phase 2 diabetic macular edema study, and NCT05197270 is a Phase 1 wet AMD study.
Yes. 4D-150 IVT and 4D-150 IVT (3E10 vg/eye) are alternative names for 4D-150, referring to intravitreal administration of the therapy. Searches using those terms refer to the same investigational program developed by 4D Molecular Therapeutics for retinal vascular diseases.