UnknownNot Applicable

A Study of Mycophenolate Mofetil Combined With Glucocorticoid Therapy in Relapse Vogt-Koyanagi-Harada Disease

China15 participantsStarted 2021-10-01

Plain-language summary

This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Subject is 18 to 70 years of age.
✓. Subjects who do not have previous, active or latent tuberculosis (TB).
✓. Subject must start Vogt-Koyanagi-Harada disease more than two months, and develop at least one recurrence.

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 (except intravitreal anti-vascular endothelial growth factor \[VEGF\] 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

What they're measuring

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

Timeframe: 24 weeks

Recurrence rate

Timeframe: 24 weeks

Trial details

NCT IDNCT05627739

SponsorTianjin Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

Contact for this trial

xiaomin Zhang

+8613920023990 xiaomzh@126.com

View on ClinicalTrials.gov More Vogt-Koyanagi-Harada Disease trials