RecruitingNot Applicable

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

China15 participantsStarted 2021-06-01

Plain-language summary

This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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.

Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.

Timeframe: 24 weeks

Recurrence rate

Timeframe: 24 weeks

NCT IDNCT05590416

SponsorTianjin Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

xiaomin zhang, M.D

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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.