Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aflibercept · 4 trials · 6 indications
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months
| Arm | Type | Description |
|---|---|---|
| Aflibercept 8 mg | EXPERIMENTAL | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
| Aflibercept 2 mg fixed | EXPERIMENTAL | Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks |
| Aflibercept 2 mg flexible | EXPERIMENTAL | Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 week |
| Aflibercept 2 mg PRN | EXPERIMENTAL | Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed) |
| Aflibercept extended dosing | EXPERIMENTAL | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). |
| Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks) | ACTIVE_COMPARATOR | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. |
| Aflibercept (Eylea) | EXPERIMENTAL | All patients recruited to the study will receive 3 loading intravitreal injections of Aflibercept (Eylea) at monthly intervals followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow-up will occur when there is evidence of OCT stability in the view of the investigator i.e. there is no further reduction in macular fluid compared to the previous visit. All patients will receive 5 injections before considering them non-responders. |
| Name | Type | Description |
|---|---|---|
| aflibercept 8 mg | DRUG | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | DRUG | - |
| Aflibercept | DRUG | 2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow up will occur where there is no reduction in macula oedema compared with the previous visit. Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye. |
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients ≥ 19 years of age at screening 3. Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagi...
Aflibercept is an investigational ophthalmology therapy in Phase 3 development for macular edema, polypoidal choroidal vasculopathy, macular degeneration, and macular oedema. It is being studied in conditions such as neovascular age-related macular degeneration, diabetic macular edema, and macular oedema with underlying retinitis pigmentosa.
Aflibercept is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is in Phase 3 clinical development for multiple ophthalmology indications, including macular degeneration and macular edema.
Aflibercept is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed across multiple indications, including neovascular age-related macular degeneration and diabetic macular edema.
Aflibercept has been studied in several clinical trials. NCT02540954 is a completed Phase 3 trial in neovascular age-related macular degeneration. NCT02661711 is a completed Phase 2 trial for macular oedema with retinitis pigmentosa. NCT02818998 is a completed Phase 3 trial in diabetic macular edema. NCT07389980 is a recruiting Phase 3 trial in polypoidal choroidal vasculopathy.
Yes, Aflibercept is also known as aflibercept 8 mg. The high-dose formulation is being evaluated in the PALLAS trial (NCT07389980) for treatment-naive polypoidal choroidal vasculopathy, with a planned enrollment of 50 participants in South Korea.
The PALLAS trial (NCT07389980) is a Phase 3, prospective study evaluating the efficacy and safety of a personalized regimen of high-dose Aflibercept 8 mg in treatment-naive polypoidal choroidal vasculopathy. It is currently recruiting in South Korea with a target enrollment of 50 participants aged 19 years and older.