Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intravitreal Aflibercept Injection (IAI), Intravitreal Aflibercept Injection
Intravitreal Aflibercept · 10 trials · 8 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.
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
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
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
Percentage of subjects converting to exudative AMD at 24 months as confirmed by independent masked reading center.
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 |
| Macular Laser Photocoagulation Treatment (Control) | SHAM_COMPARATOR | Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. |
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 | EXPERIMENTAL | Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36. |
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks. |
| 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 (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 | 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 .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 | - |
| Macular Laser Photocoagulation | PROCEDURE | - |
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | DRUG | - |
| Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) | DRUG | - |
| Intravitreal Aflibercept Injection 2mg | DRUG | - |
| Intravitreal Aflibercept Injection | DRUG | GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total). GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total). |
| 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...
Intravitreal aflibercept is an injectable ophthalmology therapy developed by Regeneron Pharmaceuticals, Inc. (ticker REGN) for retinal conditions. It is given as an injection into the eye and has been studied in age-related macular degeneration, diabetic macular edema, retinal vein occlusion, diabetic retinopathy, and central serous chorioretinopathy. It is also known as EYLEA and BAY86-5321.
Intravitreal aflibercept is used for retinal diseases including age-related macular degeneration, neovascular age-related macular degeneration, branch retinal vein occlusion, central retinal vein occlusion, diabetic macular edema, central serous chorioretinopathy, and diabetic retinopathy. Regeneron Pharmaceuticals, Inc. (REGN) is the developer. Clinical study has covered both nonproliferative and proliferative diabetic retinopathy.
Intravitreal aflibercept is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the company named as the developer of the intravitreal aflibercept injection program across its ophthalmology clinical trials.
Intravitreal aflibercept is in Phase 2 development according to its current program status, and it is investigational in the settings being studied. Its clinical program includes Phase 1, Phase 2, and Phase 3 trials, and it holds a PRIORITY_REVIEW regulatory designation. The program has 3 listed trials, with 2 completed and none currently active.
Intravitreal aflibercept has been studied in trials including NCT02718326, a Phase 3 study in moderately severe to severe nonproliferative diabetic retinopathy; NCT02462889, a Phase 2 study of prophylaxis against conversion to neovascular AMD; NCT01813773, a Phase 2 study in proliferative diabetic retinopathy; and NCT01724554, a Phase 1 study on capillary non-perfusion.
Yes, intravitreal aflibercept is also known as EYLEA and by the code BAY86-5321. Other names used for the same asset include intravitreal aflibercept injection (IAI), intravitreal aflibercept injection 2mg, and 2.0 mg intravitreal aflibercept. These names all refer to the same Regeneron Pharmaceuticals, Inc. (REGN) ophthalmology program.