Session Title: Vascular Diseases and Diabetic Retinopathy II
Session Date/Time: Friday 18/09/2015 | 16:30-18:00
Paper Time: 16:54
First Author: : C.Framme GERMANY
Co Author(s): : P. Margaron R. Hashmonay N. Eter
PURPOSE:Anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard of care for the management of patients with diabetic macular edema (DME). The current evidence in DME indicates that different anti-VEGFs are associated with similar functional responses, when adjusted for baseline visual acuity. However, variations are observed in the approved regimens, especially in the first year of treatment. The current post-hoc analysis evaluated the number of injections required in patients treated with ranibizumab pro re nata (PRN) or treat and extend (T&E) regimen compared with aflibercept during the first 12 months.
A pooled analysis was performed in patients with DME from the Phase III, double-masked RESTORE study (NCT00687804) and the Phase IIIb, single-masked RETAIN study (NCT01171976).
Patients treated with a ranibizumab PRN regimen from the RESTORE (N = 350) and RETAIN (N = 282) studies, and patients treated with a ranibizumab T&E regimen from the RETAIN (N = 242) study were included in the analysis. Ranibizumab 0.5 mg was administered in accordance with the European (EU) label with three initial consecutive monthly doses followed by flexible PRN or T&E regimens. On the other hand, the VIVID-VISTA protocol requires an initial five doses of aflibercept to be administered monthly, followed by 8-weekly (Q8w) injections in the first 12 months of treatment. The injection number distributions from baseline to Month 4 (period I) and from Month 5 to Month 12 inclusive (period II) were compared with the number of aflibercept injections required if administered according to the VIVID-VISTA protocol.
Patients treated with the ranibizumab PRN or T&E regimens received a median (mean [standard deviation]) of 4 (3.4 [0.6] and 3.8 [0.5]) injections during period I, and 3 (3.5 [2.6] and 3.7 [1.8]) injections during period II, respectively. In comparison, patients would have received a median of 5 and 4 aflibercept injections in accordance with the VIVID-VISTA protocol, during the first 12 months for periods I and II, respectively. During period I, 57% of the patients who received ranibizumab PRN and 62% of the patients who received ranibizumab T&E required a median of 4 (3.4 [0.6] and 3.8 [0.5]) or fewer injections than the patients receiving aflibercept. During period II, about 50% of the patients who received ranibizumab PRN and 55% of the patients who received ranibizumab T&E needed 3 or fewer injections. During the first 12 months, these patients received a median of 5 (5.0 [1.6]) and 7 (6.6 [1.0]) injections, respectively, compared with 9 injections in accordance with the VIVID-VISTA protocol for aflibercept. The 30% of patients receiving ranibizumab PRN who needed 0 or 1 injection during period II required a median of 4 (4.0 [1.1]) injections during the first 12 months of treatment.
This post-hoc analysis showed that in the first 12 months of treatment, most patients receiving ranibizumab PRN or T&E received fewer injections than would be required when following the VIVID-VISTA protocol for aflibercept during the initial monthly dosing period of 5 months and the subsequent Q8w period. It is shown in former DME studies that the mean visual acuity achieved at Month 12 mainly plateaued at about 70 ETDRS letters, regardless of the anti-VEGF agent and treatment regimen (Sivaprasad S, et al. ESASO 2014, Istanbul). Thus, individualized disease-activity-driven dosing regimens of ranibizumab 0.5 mg can be administered as a means of reducing treatment burden without negatively impacting the visual acuity response. The current EU label for ranibizumab permits flexible, individualized therapeutic approaches right from the beginning in patients with DME.