Abstract
Purpose :
Cumulative damage from repeated inflammatory episodes has been associated with significant visual morbidity in patients with non-infectious posterior uveitis (NIPU). The number of recurrences of uveitis over 1 year was compared among eyes treated with the FAi and those treated with a sham injection in a prospective, randomized, double-masked phase 3 clinical trial.
Methods :
Subjects with a > 1-year history of recurrent NIPU, who had experienced at least 2 separate recurrences requiring ≥ 3 months of systemic therapy or ≥ 2 intra- or periocular steroid injections, were randomized to treatment with FAi or sham. Cumulative recurrence of uveitis, defined as 1) ≥ +2 increase in anterior chamber cells; or 2) ≥ +2 increase in vitreous haze; or 3) ≥ 15-letter loss of VA; or imputed in case of missing data or rescue treatment for ocular inflammation, was compared through 1 year of the on-going 3-year clinical trial.
Results :
129 subjects (87 FAi, 42 sham) with NIPU were enrolled. During the first year of the study, the recurrence rate in FAi randomized eyes (33/87, 37.9%) was significantly lower than in sham eyes (41/42, 97.6%), p<0.001. A total of 63 recurrences were reported in FAi treated eyes (0.7±1.22/eye) versus 105 recurrences in sham treated eyes (2.5±1.67/eye). Multiple (>1) recurrences were observed in 18.4% (16/87) of the FAi treated eyes and 67% (28/42) of the sham treated eyes. Adverse events included ocular hypertension and cataract. IOP increased 1.3±3.57 and 0.2±4.17 mmHg on average in FAi and sham injection eyes, respectively.
Conclusions :
Treatment with the FAi resulted in a reduced 1-year rate of uveitic recurrences as well as cumulative total recurrent episodes. Other studies are being conducted to illustrate and confirm the benefit-to-risk profile of FAi in the management of patients with NIPU.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.