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Also known as VEGF Trap Eye, VEGF Trap-Eye (BAY86-5321)
VEGF Trap-Eye · 6 trials · 6 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.
Number of participants with AEs summarized by category
| 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 |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | EXPERIMENTAL | - |
| 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 | Intravitreal injection |
| 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 monoclonal antibody developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN) for retinal conditions. It has been studied in Phase 3 clinical trials for diabetic macular edema, macular degeneration, macular edema secondary to central retinal vein occlusion, and pathologic myopia. It is not described as approved and remains a clinical-stage asset.
VEGF Trap-Eye has been studied for diabetic macular edema, macular degeneration, macular edema, macular edema secondary to central retinal vein occlusion, and pathologic myopia. These are the indications reflected in its Phase 3 clinical development program. It is investigational, so its use is currently limited to clinical research settings rather than routine clinical practice.
VEGF Trap-Eye is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor associated with the drug's clinical development program. The asset is also referenced in trial documentation as BAY86-5321, reflecting a co-development arrangement captured in that alternate designation.
VEGF Trap-Eye is in Phase 3 clinical development. Its Phase 3 program includes completed trials in diabetic macular edema, pathologic myopia, and macular edema secondary to central retinal vein occlusion. The drug is investigational, and the available information does not indicate that it has received FDA approval for any indication.
VEGF Trap-Eye has been evaluated in completed Phase 3 trials including NCT01331681 in diabetic macular edema, NCT01512966 in Japanese patients with diabetic macular edema, NCT01249664 in choroidal neovascularization secondary to pathologic myopia, and NCT00943072 in macular edema secondary to central retinal vein occlusion. These studies were randomized, double-blind, and active-controlled.
VEGF Trap-Eye is also known as VEGF Trap Eye, VEGF Trap-Eye 2.0mg, and VEGF Trap-Eye (BAY86-5321). Trial titles in its development program refer to intravitreal aflibercept injection, indicating that VEGF Trap-Eye is the name used for the aflibercept molecule in these ophthalmic studies. The alternate names all refer to the same asset.