Abstract
Purpose :
Cumulative damage from repeated inflammatory episodes has been associated with significant visual morbidity in patients with NIPU. The number of recurrences of uveitis over 2 years 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 vitreous haze; or 2) ≥ 15-letter loss of VA; or imputed in case of rescue treatment for ocular inflammation or missing data, as well as the nature of the rescue treatments, was compared through 2 years of an on-going 3-year clinical trial.
Results :
129 subjects (87 FAi, 42 sham) with NIPU were enrolled. During the first 24M of the study, the recurrence rate in FAi randomized eyes (41/87, 47%) was significantly lower than in sham eyes (39/42, 93%), p<0.001. A total of 81 recurrences were reported in FAi treated eyes (0.9±1.7/eye) versus 126 recurrences in sham treated eyes (3.0±2.3/eye). Multiple (>1) recurrences were observed in 18% (16/87) of the FAi treated eyes and 67% (28/42) of the sham treated eyes. Intra/peri-ocular injections were used to control inflammation in 16% (14/87) and 67% (28/42) of FAi and sham eyes respectively while systemic treatments were given to 28% (24/87) and 50% (21/42) of patients. Adverse events included elevated IOP requiring medical treatment (41% FAi vs 33% sham) and cataract extractions (64% FAi vs 14% sham).
Conclusions :
A single FAi treatment resulted in a reduced rate of uveitis recurrence over 2 years as well as cumulative total recurrent episodes and consequent reduction in exposure to adjunctive anti-inflammatory medications.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.