A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group

Arch Ophthalmol. 1990 Sep;108(9):1234-44. doi: 10.1001/archopht.1990.01070110050024.


A total of 497 patients aged 18 to 56 years with insulin-dependent diabetes mellitus for 1 to 15 years were randomly assigned to take oral sorbinil or placebo and followed up for a median of 41 months. The percentage of patients whose retinopathy severity grade at maximum follow-up had worsened by two or more levels was not significantly different between the two treatment groups (28% in the sorbinil group and 32% in the placebo group, P = .344). The number of microaneurysms increased at a slightly slower rate in the sorbinil group than in the placebo group, with statistically significant differences at 21 (P = .046) and 30 (P = .039) months but not at the maximum follow-up (P = .156). About 7% of the patients assigned sorbinil developed a hypersensitivity reaction in the first 3 months. On the basis of these results, it is unlikely that sorbinil administered at a dosage of 250 mg daily for 3 years has a clinically important effect on the course of retinopathy in adults with insulin-dependent diabetes of moderate duration. Our data are consistent, however, with a slightly slower progression rate in the microaneurysm count among patients assigned to take sorbinil, a finding of uncertain clinical importance.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aldehyde Reductase / antagonists & inhibitors*
  • Aneurysm / drug therapy
  • Chi-Square Distribution
  • Diabetic Retinopathy / drug therapy*
  • Diabetic Retinopathy / enzymology
  • Drug Tolerance
  • Female
  • Follow-Up Studies
  • Humans
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Imidazolidines*
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Retinal Vessels / drug effects
  • Sugar Alcohol Dehydrogenases / antagonists & inhibitors*


  • Imidazoles
  • Imidazolidines
  • Sugar Alcohol Dehydrogenases
  • Aldehyde Reductase
  • sorbinil