Evaluating adalimumab for treating acute Vogt-Koyanagi-Harada disease

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

This study is testing if a medication called adalimumab can help people with acute Vogt-Koyanagi-Harada disease feel better compared to standard treatments like glucocorticoids.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Drugs / interventions: ranibizumab, bevacizumab, methotrexate, adalimumab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05590416 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of adalimumab in patients with acute Vogt-Koyanagi-Harada (VKH) disease compared to traditional glucocorticoid therapy. Participants will be divided into two groups: one receiving adalimumab and the other receiving standard treatments. The study will monitor various ophthalmologic outcomes over a one-year period, including visual acuity and inflammation levels. Informed consent has been obtained from all participants, and the study adheres to ethical guidelines.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with acute VKH disease diagnosed within the last month and who have not previously received systemic glucocorticoids for more than a week.

Not a fit: Patients with confirmed or suspected infectious uveitis or those who have had previous active or latent tuberculosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with acute VKH disease, potentially improving their visual outcomes.

How similar studies have performed: While the use of adalimumab in other inflammatory conditions has shown promise, this specific application in acute VKH disease is novel and has not been extensively tested.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: xiaomin zhang, M.D

Conditions Vogt-Koyanagi-Harada Disease; Adalimumab