Treatment of uveitis by oral administration of retinal antigens: results of a phase I/II randomized masked trial

Am J Ophthalmol. 1997 May;123(5):583-92. doi: 10.1016/s0002-9394(14)71070-0.


Purpose: To evaluate the effect and safety of the oral administration of retinal antigens as a treatment of ocular inflammation.

Methods: In a phase I/II randomized masked trial, patients with endogenous uveitis who were dependent on immunosuppressive agents were randomly assigned to receive either retinal S antigen alone (10 patients), retinal S antigen and a mixture of soluble retinal antigens (10 patients), a mixture of soluble retinal antigens alone (10 patients), or placebo (15 patients). An attempt was then made to taper patients completely off their standard immunosuppressive therapy over an 8 week period. The primary study endpoint was time to ocular inflammatory attack. The secondary study endpoint was the ability to taper patients completely off their immunosuppressive or cytotoxic medication within 8 weeks.

Results: Time to development of the main study endpoint was not statistically significantly different for any of the four treatment groups. However, the group receiving the purified S antigen alone appeared to be tapered off their immunosuppressive medication more successfully compared with patients given placebo (P = .08), whereas all the other groups appeared to do worse than did those receiving placebo. No toxic effects attributable to any treatment were observed.

Conclusions: This phase I/II study is the first to test the use of orally administered S antigen in the treatment of uveitis. Although not statistically significant, patients given S antigen were more likely to be tapered off their chronically administered systemic immunosuppressive therapy than were the other groups tested.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Animals
  • Antigens / administration & dosage
  • Antigens / adverse effects
  • Antigens / therapeutic use*
  • Arrestin / administration & dosage
  • Arrestin / adverse effects
  • Arrestin / therapeutic use*
  • Cattle
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Evaluation
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Life Tables
  • Male
  • Middle Aged
  • Retina / immunology*
  • Safety
  • Treatment Outcome
  • Uveitis / physiopathology
  • Uveitis / therapy*


  • Antigens
  • Arrestin
  • Immunosuppressive Agents