ABSTRACT
BACKGROUND/AIMS: Birdshot uveitis (BU) is a chronic autoimmune posterior uveitis, mostly affecting middle-aged Caucasians. There is a strong association with HLA-A29 and T-cell activation. Safety and efficacy of abatacept, an inhibitor of T-cell costimulation, is tested in active BU. METHODS: Fifteen patients with active BU were treated with monotherapy of weekly subcutaneous injections of abatacept 125 mg/mL. Time-to-treatment failure was evaluated as a primary outcome. The secondary objective was to evaluate the utility of different outcome measures to monitor disease activity. Safety was evaluated by adverse event reporting and serial blood analyses. RESULTS: At the year-1 endpoint, there was significant improvement in vitreous haze grade (p=0.0014), central choroidal thickness (CCT) (p=0.0011), Fluorescein Angiography (FA) Score (p=0.0014), Indocyanine Green Angiography (ICGA) Score (p<0.001) and total dual FA-ICGA Score (p<0.001). Best corrected visual acuity (BCVA) (p=0.8354) and central retinal thickness (CRT) (p=0.3549) did not change significantly. There were no serious adverse events reported. In total, 4 out of 15 patients left the trial during year 1 of whom 2 experienced treatment failure. CONCLUSIONS: Abatacept is very efficacious to treat both retinal vasculitis and choroiditis in patients with BU and is well tolerated. BCVA and CRT are inadequate to monitor disease activity. On the other hand, CCT is a promising non-invasive tool to detect treatment response in early active BU and dual FA-ICGA Score is very helpful to evaluate retinal vasculitis and choroiditis quantitatively. TRIAL REGISTRATION NUMBER: NCT03871361.
ABSTRACT
PURPOSE: The deleterious effects of benzalkonium chloride (BAK) on the ocular surface are well known. However, few clinical data are available to prove a toxic effect at the level of the anterior chamber. The laser flare meter is a reliable tool to detect low levels of inflammation in the anterior chamber. We wanted to know whether instillation of BAK-preserved timolol in one eye would result in higher laser flare values than the instillation of preservative-free timolol in the fellow eye. METHODS: Randomized prospective, single-masked clinical trial. Twenty-eight untreated patients with ocular hypertension were recruited. After obtaining baseline flare values, we randomly assigned one eye to BAK-preserved timolol and the fellow eye to preservative-free timolol. After 1 month, flare measurements were repeated. RESULTS: There was a significant increase in the flare values in the two treatment regimens, but the increase in the BAK-treated eyes was higher than in the preservative-free treated eyes, and this difference in increase was statistically significant. CONCLUSION: This is the first study to show that short-term BAK administration produces inflammation in the anterior segment of previously untreated patients whose blood-aqueous barrier was not affected by recent intraocular surgery.
