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Real-world outcomes after 36 months treatment with ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (BOREAL-DME)

Ophthalmic Research Sep 18, 2020

Massin P, Creuzot-Garcher C, Kodjikian L, et al. - In this prospective phase 4 observational study, researchers tested the effectiveness, safety and follow-up of 36 months treatment with ranibizumab in patients with diabetic macular edema (DME) in real life setting. Eighty-four ophthalmologists enrolled a total of 290 adult patients initiating ranibizumab for visual impairment due to DME and treated them according to their routine practice between December 2013 and April 2015. Of the 290 patients recruited, 187 (64.5%) completed the 36 months of the study (entire cohort). In this real life study, gains in best-corrected visual acuity were lower than those seen in randomized clinical trials with ranibizumab, primarily due to under treatment. The ranibizumab safety analysis did not yield any new safety concerns.

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