An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease

What this Trial Is About

Researchers are evaluating adalimumab for patients with acute Vogt-Koyanagi-Harada VKH disease to test if it provides clinical benefits. This observational study divides participants into two groups one receiving adalimumab therapy and the other receiving traditional treatment with glucocorticoids alone or combined with immunosuppressants. The study follows ethical guidelines and informed consent was obtained from all patients. In the adalimumab group, patients receive an initial subcutaneous dose of 80 mg, then 40 mg every two weeks. Therapy continues for six months after ocular inflammation subsides, followed by tapered injections until withdrawal after 40 days. The traditional therapy group follows glucocorticoid treatment starting at 1 mgkgday, gradually stopped over 90 to 180 days. The study lasts up to one year to track treatment outcomes and side effects. Participants undergo regular assessments including best corrected visual acuity BCVA, anterior chamber and vitreous inflammation, optical coherence tomography OCT, and corticosteroid dose changes. Researchers monitor anti-inflammatory and immunosuppressive effects of adalimumab, visual acuity changes, and recurrence rate at 24 weeks. Prednisone exposure is also tracked over 12 months to evaluate treatment impact and safety throughout the study period.

A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease