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    Aflibercept performance consistent in DME regardless of prior anti-VEGF therapy

    VISTA-DME/VIVID-DME trials evaluate efficacy of treatment with central involvement, BCVA


    The primary endpoint was the mean change in the BCVA at 52 weeks. Secondary endpoints included change in central retinal thickness and the Diabetic Retinopathy Severity Score at 52 and 100 weeks.

    Prior anti-VEGF treatment could have included ranibizumab (Lucentis, Genentech), bevacizumab (Avastin, Genentech), and/or pegaptanib (Macugen, Pfizer/Eyetech Pharmaceuticals).

    Visual acuity improvements

    Analysis of the mean changes in BCVA through week 100 indicated that the two aflibercept arms resulted in similar improvements in visual acuity in patients who had been treated previously and in those who were anti-VEGF treatment naïve, with increases of about 11 to 13 Early Treatment Diabetic Retinopathy study (ETDRS) letters.

    Concurrent with visual acuity improvmentsimprovements, patients treated with aflibercept experienced decreases in central retinal thicknesses that ranged from about 160 to 190 µm regardless of prior anti-VEGF treatment status.

    At week 100, 35.8% of patients with DME who had received previous anti-VEGF therapy and then 2 mg of aflibercept every 4 weeks had a gain of 15 or more ETDRS letters, as did 29.4% of patients who received 2 mg of aflibercept every 8 weeks following 5 monthly doses, Dr. Wykoff said.

    Those values were significantly better than patients treated with focal macular laser, with 7.9% achieving a gain of 15 or more letters. Comparable visual acuity improvements were achieved in anti-VEGF treatment-naïve patients, 40.2% and 36.1%, respectively, in contrast to 16.5% in the laser-treated group.

    At week 100, among patients treated previously with anti-VEGF therapy, 15.9% of laser-treated patients, 37.3% of patients treated with 2 mg of aflibercept every 4 weeks, and 38.2% of those treated 2 mg of aflibercept every 8 weeks after 5 monthly doses had an improvement in the Diabetic Retinopathy Severity Score of two or more steps.

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