Treatment of uveitis by oral administration of retinal antigens: results of a phase I/II randomized masked trial.
OBJECTIVE
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.
Nussenblatt
R B
RB
Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD 20892-1858, USA. rnq@helix.nih.gov
Gery
I
I
Weiner
H L
HL
Ferris
F L
FL
Shiloach
J
J
Remaley
N
N
Perry
C
C
Caspi
R R
RR
Hafler
D A
DA
Foster
C S
CS
Whitcup
S M
SM
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000941:Antigens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019393:Arrestin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D012160:Retina / Q000276:immunology*; D012449:Safety; D016896:Treatment Outcome; D014605:Uveitis / Q000503:physiopathology / Q000628:therapy*
D000941:Antigens; D019393:Arrestin; D007166:Immunosuppressive Agents