The Efficacy and Safety of Adalimumab in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05015335
Phase
PHASE4
Status
Unknown

Conditions

  • Adalimumab
  • Uveitis, Anterior

Eligibility Criteria

Sex
ALL
Age
4 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    ADA 40mg q2w
  • Methotrexate — DRUG
    MTX 10mg qw

Study Details

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.

Key Dates

Start date
Aug 19, 2021
Status verified
Jul 2021
Primary completion
Jul 31, 2022
Completion
Jul 31, 2023

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Adalimumab
    Adalimumab administered subcutaneously at 40mg every 2 weeks
  • Active Comparator: Methotrexate
    Methotrexate given 10mg orally once a week.

Primary Outcome Measure

Uveitis flare [ Time Frame: At 6 months' follow-up visit ]

Central Contacts

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