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Carsten Framme, Philippe Margaron, Ron Hashmonay, Nicole Eter; Ranibizumab 0.5 mg injections required within the first year of a flexible treatment regimen in diabetic macular edema patients: a post-hoc analysis of RESTORE and RETAIN. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1739.
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Current evidence in diabetic macular edema (DME) indicates that different anti-VEGFs are associated with similar functional responses, when adjusted for baseline visual acuity (Sivaprasad S et al. Ophthalmologica 2014;232(suppl 2):19; Regnier S et al. PLoS One. 2014 Jul 16;9(7):e102309). However, the approved regimens differ, especially in the first year; the European ranibizumab (RBZ; 0.5 mg) label allows for flexible regimens such as pro re nata (PRN) or treat-and-extend (TE), whereas the European label for aflibercept (AFL) requires 5 monthly doses followed by 8-weekly injections (Q8w) in the first year. We evaluated the number of injections required in patients treated with RBZ PRN or TE during the first 12 months (M).
A pooled analysis of DME patients treated with RBZ PRN from RESTORE (N=350; http://clinicaltrials.gov, NCT00687804, registered on 05-27-2008, study start 05-2008) and RETAIN (N=282) and patients treated with RBZ TE from RETAIN (N=242) was conducted. Injection number distributions from baseline to M4 (phase I), and from M5 to M12 inclusive (phase II) were compared to the number of AFL injections required according to the European label.
Patients treated with RBZ PRN or TE received a median (mean [SD]) of 4 (3.4 [0.6]) and (3.8 [0.5]) injections, respectively, during phase I, and 3 (3.5 [2.6]) and (3.7 [1.8]) injections during phase II, compared to the 5 and 4 AFL injections they would have received as per the AFL label, respectively. During phase I, 57% and 62% of PRN and TE recipients required 4 (3.4 [0.6]) and (3.8 [0.5]) or fewer injections, respectively. In phase II, about 50% and 55% of PRN and TE patients, respectively, needed 3 or fewer injections. These patients received a median of 5 (5.0 [1.6]) and 7 (6.6 [1.0]) injections, respectively, during the first year, compared to 9 injections per AFL label. The 30% of PRN patients who needed 0 or 1 injection during phase II required a median of 4 (4.0 [1.1]) injections in the first year.
In the first year, most patients receiving RBZ PRN or TE had fewer injections than would be required when following the European label for AFL during both the loading phase and the subsequent Q8w period. The current European RBZ label permits flexible, individualized therapeutic approaches, while reducing treatment burden to DME patients.
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