The Efficacy and Safety of Adalimumab in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
Children with anterior uveitis are prone to suffer from chronic recurrent course of
intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory
treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable
in treating refractory non-infectious uveitis. This study aims to assess the efficacy and
safety of adalimumab for inflammatory flare prevention in non-infectious anterior pediatric
uveitis with peripheral vascular leakage compared with methotrexate. Children weighed ≥ 30kg
and aged between 4-16 years old with active chronic non-infectious anterior uveitis with
peripheral retinal vascular leakage on ultra wildfield fluorescence fundus angiography
(UWFFA) will be included. They will be treated with a predesigned inflammatory control
regimen to reach inflammatory quiescence in 1 month. After that they will be treated with
either MTX or adalimumab and regularly followed up for at least 6 months. The primary
endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell
count grading increased from 0 to 1. Secondary endpoints are best corrected visual acuity
(BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of
vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug
load, and adverse events.