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VEGF Trap · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| ITV-1 | EXPERIMENTAL | VEGF Trap formulation 1 |
| ITV-2 | EXPERIMENTAL | VEGF Trap formulation 2 |
| ITV-2 OL | EXPERIMENTAL | VEGF Trap formulation 2 open label, higher concentration |
| Part A | EXPERIMENTAL | Part A: An open label study in which six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. The total volume of each injection will be 100 μL. Enrollment in new dose levels will not begin until all patients in the preceding dose level have completed Visit 5 (Day 15). |
| Part B | ACTIVE_COMPARATOR | Part B: A controlled, prospective, randomized, double-masked study in which up to 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive a single ITV injection of2.0 mg/eye VEGF Trap (or the MTD if reached prior to 2.0 mg) followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Enrollment into Part B will begin 2 weeks after the last subject to receive the 2.0 mg/eye dose in Part A has been observed for 15 days and it has been determined that the safety profile of VEGF Trap at this dose level is adequate to support expansion of dosing at this dose level. The dose of pegaptanib sodium will be 0.3 mg, according to the package insert. |
| Part C | ACTIVE_COMPARATOR | Part C: A controlled, prospective, randomized, double-masked study in which approximately 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. Initiation of Part C is contingent upon the 4.0 mg dose being adequately tolerated in Part A. |
| Name | Type | Description |
|---|---|---|
| VEGF Trap | DRUG | VEGF Trap formulation 1, ITV-1 |
Inclusion Criteria: * Subfoveal CNV secondary to AMD. * Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT. * ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters) Exclusion Criteria: * No prior treatment with the following in the study eye: * Su...
VEGF Trap is an investigational small molecule being studied for the treatment of neovascular age-related macular degeneration and macular degeneration. It is administered via intravitreal injection and is currently in Phase 1 clinical development.
VEGF Trap is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and tolerability of the drug.
VEGF Trap is in Phase 1 clinical development. Two Phase 1 trials have been completed, each evaluating the safety and tolerability of intravitreal VEGF Trap administration in patients with neovascular age-related macular degeneration.
VEGF Trap has been studied in two completed Phase 1 clinical trials: NCT00320775, which enrolled 51 patients with macular degeneration, and NCT00383370, which enrolled 20 patients with neovascular age-related macular degeneration. Both trials were conducted in the United States.
VEGF Trap is the investigational name for the drug that is also known as aflibercept. The clinical trials listed under the name VEGF Trap evaluate the same active agent, which is being developed by Regeneron Pharmaceuticals for ophthalmic use.