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Results in Regeneron's (REGN) Phase 3 Non Proliferative Diabetic Retinopathy Trial of EYLEA (aflibercept) Injection

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Clinical Data PANORAMA is an ongoing, pivotal, double-masked, randomized two-year trial that enrolled 402 patients and is designed to investigate EYLEA for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. Details on trial design include: Š Three treatment arms - An observational sham injection group and two EYLEA treatment groups. The EYLEA treatment groups started with either three or five initial monthly doses, and the trial will evaluate every eight-week dosing or every 16-week dosing at one year. Š Two primary endpoints - Both assess the proportion of patients who experience a two-step or greater improvement in DRSS score from baseline. The first is measured at six months (24 weeks) and the second at one year (52 weeks). The DRSS is a systematic grading scale to assess the severity of diabetic retinopathy based on photographs of the retina following a dilated eye exam. Š Key secondary endpoints - These include assessment of whether EYLEA prevents neovascular vision-threatening complications (such as progression to proliferative diabetic retinopathy (PDR) and anterior segment neovascularization) or progression to DME, as well as its impact on other anatomic effects, visual acuity improvement, and safety. Some secondary endpoints will be measured for up to two years. 
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Occurred on:
Mar 19, 2018
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Related Keywords Eylea, Aflibercept, Diabetic Retinopathy, Panorama