Effect of Nilvadipine on Central Visual Field in Retinitis Pigmentosa: A 30-Month Clinical Trial

Purpose: To assess the effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa (RP). Design: Prospective, randomized, nonmasked, single-center trial. Methods: Patients with RP were randomly divided into a treated group receiving oral nilvadipine at 4 mg/day for 6 30 months and a control group receiving tocopherol nicotinate at 300 mg/day, helenien at 15 mg/day or no medication for the same periods. Progression of RP was evaluated using the 10-2 SITA Fast Program of the Humphrey Visual Field Analyzer, and regression coefficients calculated from the time courses of mean deviation (MD slope) were compared between groups. Results: Nineteen patients in the treated group and 14 patients in the control group completed the follow-up for >= 30 months. The mean (+/- standard deviation) duration of observation was 48.8 +/- 11.8 months (median 48 months, range 30-66 months) for the treated group and 49.2 +/- 18.1 months (median 48 months, range 30-90 months) for the control group (p = 0.94). Mean (+/-standard error of the mean, SEM) regression coefficients of the averaged MD values for the initial 30 months were -0.35 +/- 0.17 dB/year in the treated group and -0.75 +/- 0.06 dB/year in the control group (p < 0.01). Mean (+/-SEM) MD slopes for total observational periods were -0.49 +/- 0.17 dB/year in the treated group and -0.89 +/- 0.16 dB/year in the control group (mean +/- SEM, p = 0.042). Conclusion: Nilvadipine at 4 mg/day significantly retarded progression of central visual field defects in RP in this small patient series. Copyright (C) 2010 S. Karger AG, Basel