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Paul Mitchell, RESTORE extension study group; 2-year Safety And Efficacy Outcome Of Ranibizumab 0.5 mg In Patients With Visual Impairment Due To Diabetic Macular Edema (DME): An Interim Analysis Of The Restore Extension Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4667.
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Evaluate the safety and efficacy of ranibizumab 0.5 mg (RBZ) in patients (pts) with visual impairment due to DME in the RESTORE extension study.
240 of 303 pts who completed RESTORE core study (Day1-M12) entered the extension study (M12-M36); all pts (RBZ/RBZ+laser/laser) were eligible to receive RBZ pro-re-nata (PRN) according to pre-specified best-corrected visual acuity (BCVA) stability-based treatment criteria. Pts were eligible to receive laser according to Early Treatment Diabetic Retinopathy Study guidelines. Here we report the 2-year interim analysis outcome of the incidence of adverse events (AEs), treatment exposure, and changes in BCVA and visual function (VF, assessed by Visual Functioning Questionnaire [VFQ-25]).
91.7% (220/240) pts who entered the extension phase had a M24 visit. The 2-year incidences of AEs were similar to previously reported safety results of RBZ in DME and other indications; no new AEs and no cases of endophthalmitis occurred in this study. There were 4 deaths, none of these was suspected to be related to study drug. The gained BCVA and VF observed in the core study were maintained through M24.
The AEs reported in the interim analysis were consistent with the published safety profile of RBZ in DME. Overall, an average of 3.8 RBZ injections was sufficient to maintain BCVA and VF in the first year RESTORE extension phase. These data provide further evidence for long-term safety and efficacy of RBZ treatment in DME.
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