Status:
RECRUITING
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Lead Sponsor:
Tianjin Medical University
Conditions:
Vogt-Koyanagi-Harada Disease
Adalimumab
Eligibility:
All Genders
18-70 years
Brief Summary
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Detailed Description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written infor...
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 to 70 years of age.
- Subjects who do not have previous, active or latent tuberculosis (TB).
- Subject must have Vogt-Koyanagi-Harada disease less than one month.
- Subject who were previously treated with systemic glucocorticoid less than one week.
- 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:
- 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).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- 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).
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05590416
Start Date
June 1 2021
End Date
December 30 2024
Last Update
July 3 2024
Active Locations (1)
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1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000