Using Mycophenolate Mofetil with Glucocorticoids for Relapse Vogt-Koyanagi-Harada Disease

An Observational Study of Mycophenolate Mofetil Combined With Glucocorticoid in the Treatment of Relapse Vogt-Koyanagi-Harada Disease

This study is testing if adding a medication called Mycophenolate Mofetil to glucocorticoids can help people with a relapse of Vogt-Koyanagi-Harada disease feel better.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Drugs / interventions: ranibizumab, bevacizumab, methotrexate
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05627739 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of Mycophenolate Mofetil (MMF) combined with glucocorticoid therapy in patients experiencing relapse of Vogt-Koyanagi-Harada (VKH) disease. Participants will be divided into two groups: one receiving MMF and glucocorticoids, and the other receiving traditional glucocorticoid therapy alone or with Cyclosporine. The study will monitor patients for up to one year, assessing outcomes such as visual acuity, inflammation levels, and corticosteroid dosage changes. The methodology adheres to ethical standards and includes informed consent from all participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a history of VKH disease and at least one recurrence.

Not a fit: Patients with active or latent tuberculosis or those with infectious uveitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with relapse VKH disease, potentially improving their visual outcomes.

How similar studies have performed: While the use of MMF in similar conditions has shown promise, this specific combination therapy in VKH disease is relatively novel and not extensively tested.

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

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 (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 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

Where this trial is running

Tianjin, Tianjin

• xiaomin Zhang — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: xiaomin Zhang

Conditions Vogt-Koyanagi-Harada Disease; Mycophenolate Mofetil