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

Launched by TIANJIN MEDICAL UNIVERSITY · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called adalimumab for treating a condition known as acute Vogt-Koyanagi-Harada disease, which affects the eyes and can lead to vision problems. The trial aims to see if adalimumab can help patients who have had this condition for less than a month and may have decided against using traditional steroid treatments due to their side effects.

To participate in this study, individuals must be between 18 and 70 years old and should not have had certain infections or past treatments that could interfere with the results. Participants will be monitored closely and may receive adalimumab to see how well it works for their condition. This trial is currently recruiting, so if you or someone you know fits the criteria and is interested in learning more, it could be a valuable opportunity to help improve treatment options for this eye disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is 18 to 70 years of age.
• • 2. Subjects who do not have previous, active or latent tuberculosis (TB).
• • 3. Subject must have Vogt-Koyanagi-Harada disease less than one month.
• • 4. Subject who were previously treated with systemic glucocorticoid less than one week.
• 5. Subject meets at least 1 of the following criteria:
• • 1)patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).
• Exclusion Criteria:
• • 1. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
• • 2. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
• • 3. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
• • 4. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
• • 5. Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
• • 6. Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.