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Real-World Outcomes with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema: 12-Month Results from the 36-Month BOREAL-DME Study

dc.rights.licenseopenen_US
dc.contributor.authorMASSIN, P.
dc.contributor.authorCREUZOT-GARCHER, C.
dc.contributor.authorKODJIKIAN, L.
dc.contributor.authorGIRMENS, J. F.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDELCOURT, Cecile
dc.contributor.authorFAJNKUCHEN, F.
dc.contributor.authorGLACET-BERNARD, A.
dc.contributor.authorGUILLAUSSEAU, P. J.
dc.contributor.authorPONTHIEUX, A.
dc.contributor.authorBLIN, Patrick
dc.contributor.authorGRELAUD, A.
dc.date.accessioned2020-06-29T10:02:56Z
dc.date.available2020-06-29T10:02:56Z
dc.date.issued2019-03-29
dc.identifier.issn1423-0259 (Electronic) 0030-3747 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/8266
dc.description.abstractEnPURPOSE: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). METHODS: This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged >/=18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, preci sion = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. RESULTS: Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (+/- standard deviation) was 66.1 +/- 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 mum (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA > 70 letters versus 13.2% at baseline. Mean change in CSFT was -125 mum (95% CI: -146, -103). The mean number of ranibizumab injections was 5.1 +/- 2.3 over an average of 10.4 +/- 3.0 visits. No new safety findings were identified. CONCLUSIONS: The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials.
dc.language.isoENen_US
dc.subject.enLEHA
dc.title.enReal-World Outcomes with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema: 12-Month Results from the 36-Month BOREAL-DME Study
dc.typeArticle de revueen_US
dc.identifier.doi10.1159/000497406en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed30928985en_US
bordeaux.journalOphthalmic researchen_US
bordeaux.page101-110en_US
bordeaux.volume62en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue2en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamLEHA_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
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