Effect of nilvadipine on central visual field in retinitis pigmentosa: a 30-month clinical trial

Ophthalmologica. 2011;225(2):120-6. doi: 10.1159/000320500. Epub 2010 Oct 16.

Abstract

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 ≥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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Calcium Channel Blockers / therapeutic use*
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Humans
  • Lutein / analogs & derivatives
  • Lutein / therapeutic use
  • Male
  • Middle Aged
  • Nifedipine / analogs & derivatives*
  • Nifedipine / therapeutic use
  • Pilot Projects
  • Prospective Studies
  • Retinitis Pigmentosa / drug therapy*
  • Retinitis Pigmentosa / physiopathology
  • Tocopherols / therapeutic use
  • Vision Disorders / physiopathology
  • Vision Disorders / prevention & control*
  • Visual Field Tests
  • Visual Fields / drug effects*
  • Visual Fields / physiology
  • Young Adult

Substances

  • Calcium Channel Blockers
  • nilvadipine
  • Nifedipine
  • Tocopherols
  • xanthophyll dipalmitate
  • Lutein