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Pascale Massin, Laurent Kodjikian, Marie Laure Lelez, Ali Erginay, Stéphane Quéré, Véronique Schneider, LUDIC Study Group; Real-life use of ranibizumab in the treatment of diabetic macular edema: results on visual acuity at month 6 in a French Phase IV study (LUDIC study). Invest. Ophthalmol. Vis. Sci. 2013;54(15):2388.
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Purpose: To describe the visual acuity (VA) results from a prospective interventional phase IV study designed to investigate efficacy in real-life use of ranibizumab in diabetic macular edema (DME), and compare it with that observed in RESTORE, a key development study
LUDIC is an open-label single-arm study. Patients recruited at 46 centers were given three monthly injections of ranibizumab and retreated if necessary in strict application of the current Summary of Product Characteristics (SmPC). In contrast with the development studies, no exclusion criteria related to prior treatment for DME were imposed.
Between February and December 2011, 350 patients were enrolled. At baseline mean age was 63.7 years, diabetes had been diagnosed for 18 years and DME had been diagnosed for 2.2 years (mean values). Mean baseline VA was 57.0 ± 10.3 letters, versus 64.7 letters in RESTORE. 48.1% of patients had been treated by laser photocoagulation during the preceding 12 months and 19.7% had been treated with IVT anti-VEGF. The proportion of patients demonstrating a 10 letters gain from baseline after 6 months of IVT ranibizumab treatment (primary endpoint) was 39.9%, versus 34.8% in RESTORE. The mean change in VA from baseline after 6 months was 7.1 ± 10.2 ETDRS letters (6.7± 7.3 in RESTORE at 6 months). The correlation coefficient between gain in VA after 3 consecutive injections and VA at M6 was 0.6678 (p<0.0001). The mean number of injections needed to achieve a VA gain ≥10 letters was 2.3 ± 1.3 injections; the mean number required to achieve stable VA (variation <3 letters) for three consecutive visits was 3.9 ± 1.0.
This phase IV study conducted in a real world setting showed VA gains comparable to those observed in the pivotal study RESTORE despite lower VA at baseline and including patients with broader range of medical histories pretreatments. This confirms the effectiveness of the individualised treatment regimen as recommended in the Lucentis® SmPC and the relevance of the RESTORE study.
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