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Ali Erginay, Pascale Massin, Laurent Kodjikian, Marie-Laure Le Lez, Stéphane Quéré, Véronique Schneider, LUDIC Study Group; Real-life use of ranibizumab in the treatment of diabetic macular edema: the population of a French Phase IV Study (LUDIC study). Invest. Ophthalmol. Vis. Sci. 2013;54(15):2406.
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To describe the population of a French Phase IV interventional study designed to investigate efficacy in real-life use of ranibizumab in diabetic macular edema (DME), and compare it with that observed in the key development study (the RESTORE 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. In contrast with the development studies, no exclusion criteria related to prior treatment for DME were imposed in this prospective interventional phase IV study.
Between February and December 2011, 350 patients were enrolled. Eligibility criteria for RESTORE were relatively strict especially concerning previous treatment: the exclusion criteria included panretinal laser photocoagulation in the preceding 6 months and either focal/grid laser photocoagulation or any form of intraocular treatment with anti-angiogenic products within 3 months of randomization. No such criteria were applied in LUDIC: 48.1% of the study population had been treated by laser photocoagulation during the preceding 12 months and 19.7% had been treated with IVT anti-VEGF. At baseline, mean age was 63.7 years, male/female ratio was 1.6 and 79.4% were overweight (39.3 % obese); 79.1% had hypertension, 59.1% dyslipidaemia and 69.1% glycosylated haemoglobin above 7%. The percentage in whom the diabetes was controlled (applying the RESTORE criterion of <8% HbA1c) was similar (70.0% in LUDIC versus 72.4% in RESTORE). Diabetes (type 1 in 20.6%) had been diagnosed 18 years previously on average and all were being actively treated. DME had been diagnosed an average of 2.2 years previously. Mean baseline VA was 57.0 ± 10.3 letters and was also worse in LUDIC with 58.9% of patients not able to read more than 60 ETDRS letters compared with 32.8% of the RESTORE population.
This cohort—the largest to date of French patients with DME treated with ranibizumab—is comparable to that of the RESTORE Study in terms of age and gender but diabetes and DME are more severe in this real-life population which is likely to be closer to the true target DME population.
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