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:

  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.

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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Page 1 of 1 (1 locations)

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Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China, 300000

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