Adjuvant 5-fluorouracil and heparin prevents proliferative vitreoretinopathy : Results from a randomized, double-blind, controlled clinical trial

Ophthalmology. 2001 Jul;108(7):1179-83. doi: 10.1016/s0161-6420(01)00589-9.


Purpose: To assess the safety and efficacy of adjuvant combination therapy using 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) for prevention of proliferative vitreoretinopathy (PVR) after vitrectomy and retinal reattachment surgery.

Design: Prospective randomized, double-masked, placebo controlled trial.

Participants: One hundred seventy-four high-risk patients were randomized to receive either 5-FU and LMWH therapy or placebo. Patients were selected from all patients undergoing primary vitrectomy for rhegmatogenous retinal detachment.

Method: Results of standard surgery with 5-FU and LMWH therapy or placebo were compared at the 6-month follow-up.

Main outcome measures: Development of postoperative PVR, retinal reattachment at 6 months after surgery, single operation reattachment rate, number of reoperations, and best-corrected visual acuity.

Results: There were 87 patients in the 5-FU and LMWH therapy group and 87 in the placebo group. The incidence of postoperative PVR was significantly lower (P = 0.02) in the 5-FU and LMWH therapy compared with the placebo group. In 26.4% (23/87) of the placebo group and in 12.6% (11/87) of the 5-FU and LMWH group, postoperative PVR developed. In the 5-FU and LMWH group, the number of patients undergoing more than one operation was 19.5% (17/87) and the number of reoperations resulting from PVR was 52.9% (9/17). In the placebo group, the number of patients undergoing more than one operation was 25.3% (22/87) and the number of reoperations resulting from PVR was 72.7% (16/22). The difference in visual acuity was not statistically different in the two treatment groups, although those patients in whom postoperative PVR developed tended to have poorer vision (P < 0.0001). There were no differences in complication rates between the two groups.

Conclusions: There is a significant reduction in the incidence of postoperative PVR in patients receiving the 5-FU and LMWH therapy and in the reoperation rate resulting from PVR. This trial shows that incidence of PVR can be reduced with inexpensive and simple pharmacologic treatment with 5-FU and LMWH and should be used routinely in the treatment of patients at risk of developing PVR.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / therapeutic use*
  • Follow-Up Studies
  • Heparin, Low-Molecular-Weight / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Retinal Detachment / surgery
  • Risk Factors
  • Safety
  • Visual Acuity
  • Vitrectomy / adverse effects
  • Vitreoretinopathy, Proliferative / etiology
  • Vitreoretinopathy, Proliferative / prevention & control*


  • Heparin, Low-Molecular-Weight
  • Fluorouracil