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

Last updated: December 6, 2023
Sponsor: Tianjin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Posterior Uveitis

Treatment

Mycophenolate Mofetil

Clinical Study ID

NCT05627739
2022KY-28
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 start Vogt-Koyanagi-Harada disease more than two months, and develop atleast one recurrence.

Exclusion

Exclusion Criteria:

  1. Subject with confirmed or suspected infectious uveitis, including but not limited toinfectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosisand herpes simplex virus (HSV).
  2. Subject with corneal or lens opacity that precludes visualization of the fundus orthat likely requires cataract surgery during the duration of the trial.
  3. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or anybiologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF]therapy) with a potential therapeutic impact on non-infectious uveitis.
  4. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to theBaseline visit.
  5. Subject has received intravitreal anti-VEGF therapy within 45 days of the Baselinevisit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of theBaseline visit for anti-VEGF Trap (aflibercept).
  6. Subject has received intravitreal methotrexate within 90 days prior to the Baselinevisit

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Mycophenolate Mofetil
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
December 01, 2025

Study 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 informed consent and received a thorough explanation of the use of Mycophenolate Mofetil, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with relapse VKH divided into two groups: Mycophenolate Mofetil therapy group and traditional therapy group.

For Mycophenolate Mofetil therapy group, an initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. Study participants will be followed for up to one year to determine efficacy and side effects.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of MMF in treatment of relapse VKH.

Connect with a study center

  • xiaomin Zhang

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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