A randomized phase II trial of interferon-alpha2b versus 5-fluorouracil after trabeculectomy

Aust N Z J Ophthalmol. 1999 Feb;27(1):37-44. doi: 10.1046/j.1440-1606.1999.00165.x.


Purpose: The aim of the present study was to investigate the safety and potential efficacy of subconjunctival interferon-alpha2b (IFN-alpha), either alone or in combination with 5-fluorouracil (5-FU), in reducing the risk of failure of glaucoma surgery

Methods: A prospective, masked randomized phase II study was undertaken in which patients received three subconjunctival injections per week for 3-4 weeks postoperatively. Three treatments were compared: (i) IFN-alpha (1 x 10(6)IU per dose); (ii) 5-FU (5 mg per dose); and (iii) alternating IFN-alpha and 5-FU (BOTH). The primary outcome measures were: (i) rate of successful control of intra-ocular pressure without further surgery; and (ii) the incidence of side effects.

Results: Fifty-seven patients undergoing glaucoma surgery with an increased risk of failure were evaluated, including 23 patients (40%) undergoing trabeculectomy combined with extracapsular cataract extraction as well as other conventional high-risk groups. With 53 patients (93%) completing 2 years follow up,there was no significant difference in success rates among the three groups. Intra-ocular pressure was controlled without further surgery in 79% of patients (95% confidence interval (CI): 61, 97%) receiving IFN-alpha, in 89% of patients (76, 100%) receiving 5-FU and in 89% of patients (76, 100% receiving BOTH. Side effects were similar among the three groups.

Conclusions: These results are consistent with a beneficial effect of IFN-alpha2b given either alone or in combination with 5-FU after glaucoma filtering surgery. However, the lack of a clear and substantial benefit over conventional anti-fibrotic therapy does not support the further clinical evaluation of these treatments.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cataract / complications
  • Cataract Extraction
  • Connective Tissue / pathology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fibrosis / prevention & control
  • Fluorouracil / therapeutic use*
  • Glaucoma / complications
  • Glaucoma / drug therapy*
  • Glaucoma / surgery*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / therapeutic use*
  • Intraocular Pressure
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins
  • Safety
  • Trabeculectomy*
  • Treatment Outcome


  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Fluorouracil