Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intravitreal Aflibercept · 8 trials · 7 indications
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline.
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Percentage of subjects converting to exudative AMD at 24 months as confirmed by independent masked reading center.
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.
| Arm | Type | Description |
|---|---|---|
| Ranibizumab | ACTIVE_COMPARATOR | - |
| Aflibercept | EXPERIMENTAL | - |
| Bevacizumab | EXPERIMENTAL | - |
| Dosing regimen 1 | EXPERIMENTAL | Participants will receive IVT aflibercept dosing regimen 1 |
| Dosing regimen 2 | EXPERIMENTAL | Participants will receive IVT aflibercept dosing regimen 2 |
| Dosing regimen 3 | SHAM_COMPARATOR | Participants will receive matching sham injections |
| Open-label Intravitreal Aflibercept Injection | EXPERIMENTAL | Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above. |
| Intravitreal aflibercept injection | EXPERIMENTAL | Subjects will be randomized to receive intravitreal aflibercept injection every three months for 24 months. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized to receive sham injection every three months for 24 months. |
| Group A - IAI every 4 weeks | EXPERIMENTAL | Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will continue to receive IAI every 4 weeks, beginning week 20, through week 48. |
| Group B - IAI every 8 weeks | EXPERIMENTAL | Receives 5 injections of Intravitreal Aflibercept Injection (IAI) beginning Day 1, and then at weeks 4, 8, 12, and 16. Following the 5 initial injections, this group will receive IAI every 8 weeks, beginning week 24, through week 48. |
| Intravitreal Aflibercept Injection (x4) | EXPERIMENTAL | 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). |
| Intravitreal Aflibercept Injection (x6) | EXPERIMENTAL | 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times). |
| Intravitreal Aflibercept Injection .5Q4 | EXPERIMENTAL | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks |
| Intravitreal Aflibercept Injection 2Q4 | EXPERIMENTAL | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks |
| Intravitreal Aflibercept Injection 2Q8 | EXPERIMENTAL | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks |
| Intravitreal Aflibercept Injection 2PRN | EXPERIMENTAL | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria |
| Laser Photocoagulation | ACTIVE_COMPARATOR | Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks. |
| Every Month Treatment | EXPERIMENTAL | Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study. |
| Every Month, then Every Other Month | EXPERIMENTAL | Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed. |
| Name | Type | Description |
|---|---|---|
| 2.0 mg intravitreal aflibercept | DRUG | Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria. |
| 1.25 mg intravitreal bevacizumab | DRUG | Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria. |
| 0.3 mg intravitreal ranibizumab | DRUG | Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria. |
| Intravitreal aflibercept injection [IAI] | DRUG | - |
| Sham | DRUG | - |
| Intravitreal Aflibercept Injection 2mg | DRUG | - |
| Intravitreal aflibercept injection | DRUG | Intravitreal aflibercept injection |
| Placebo | DRUG | Sham injection |
| Intravitreal Aflibercept Injection (IAI) | DRUG | EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells. |
| Laser Photocoagulation | PROCEDURE | laser every 16 weeks as needed |
Inclusion Criteria: * Age ≥ 18 years * Individuals \<18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable. * Diagnosis of diabetes mellitus (type 1 or type 2) * Any one of the following will be considered to be sufficient evidenc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Intravitreal Aflibercept is an investigational small molecule being developed for ophthalmology indications including Central Retinal Vein Occlusion, Central Serous Chorioretinopathy, Nonproliferative Diabetic Retinopathy, Neovascular Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, and Diabetic Macular Edema. It is administered by intravitreal injection and is currently in Phase 1 clinical development.
Intravitreal Aflibercept is being developed by Regeneron Pharmaceuticals, Inc., which trades on the NASDAQ under the ticker REGN. The company is conducting clinical trials of this investigational therapy for multiple retinal and macular conditions.
Intravitreal Aflibercept is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted it Priority Review designation, though it remains in clinical trials and is not yet available as a marketed therapy.
Intravitreal Aflibercept has completed two clinical trials: NCT00789477, a Phase 2 study in Diabetic Macular Edema with 221 participants, and NCT00964795, a Phase 3 open-label extension in Neovascular Age-related Macular Degeneration with 323 participants. Both trials are completed.
Yes, Intravitreal Aflibercept is also known as EYLEA and BAY86-5321. Clinical trial records refer to it as Intravitreal Aflibercept Injection (IAI; EYLEA; BAY86-5321), confirming these names refer to the same drug being developed by Regeneron.