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VEGF Trap-Eye · 5 trials · 5 indications
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
| Arm | Type | Description |
|---|---|---|
| VTE 2Q4 first, then VTE 2Q8 | EXPERIMENTAL | VEGF Trap-Eye \[BAY86-5321; EYLEA (aflibercept) Injection\] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) |
| Intravitreal Aflibercept Injection 2Q4 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| Intravitreal Aflibercept Injection 2Q8 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8). |
| Macular Laser Photocoagulation (Control) | ACTIVE_COMPARATOR | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | SHAM_COMPARATOR | - |
| VEGF Trap-Eye | EXPERIMENTAL | Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint |
| Sham | SHAM_COMPARATOR | Monthly Sham IVT injection until Week 24 Primary Endpoint |
| Name | Type | Description |
|---|---|---|
| VEGF Trap-Eye (BAY86-5321) | BIOLOGICAL | Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks. |
| Macular Laser Photocoagulation (Control) | PROCEDURE | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
| No Drug | PROCEDURE | Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea |
| VEGF Trap-Eye 2.0mg | BIOLOGICAL | Monthly intravitreal injection out to the Week 24 Primary endpoint |
| Sham | DRUG | Monthly sham intravitreal injection out to Week 24 Primary Endpoint |
| VEGF Trap-Eye | DRUG | single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1 |
Inclusion Criteria: * Adults ≥ 18 years with type 1 or 2 diabetes mellitus * Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye * BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter ...
VEGF Trap Eye is an investigational ophthalmology treatment being studied for macular degeneration, diabetic macular edema, macular edema, pathological myopia, and macular edema secondary to central retinal vein occlusion. It is a small molecule developed by Regeneron Pharmaceuticals for use in eye conditions related to abnormal blood vessel growth and fluid leakage.
VEGF Trap Eye works by targeting vascular endothelial growth factor (VEGF), a protein that promotes abnormal blood vessel growth and leakage in the eye. By binding to VEGF, the drug aims to reduce this activity, which is thought to contribute to conditions like macular degeneration and diabetic macular edema.
VEGF Trap Eye is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting clinical research on this investigational therapy for multiple eye conditions.
VEGF Trap Eye is in Phase 2 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, with the most advanced completed study being a Phase 3 trial. However, it remains investigational and is not yet approved by regulatory authorities.
VEGF Trap Eye has been studied in several completed trials, including NCT00320814 (Phase 1 in diabetic macular edema), NCT00527423 (Phase 2 in macular degeneration), NCT00943072 (Phase 3 in macular edema secondary to central retinal vein occlusion), and NCT01331681 (Phase 3 in vision impairment due to diabetic macular edema).
Yes, VEGF Trap Eye is also known as aflibercept. One of its Phase 3 trials, NCT01331681, is titled 'Intravitreal Aflibercept Injection in Vision Impairment Due to DME,' confirming that VEGF Trap Eye and aflibercept refer to the same drug.