A Study of Mycophenolate Mofetil Combined With Glucocorticoid Therapy in Relapse Vogt-Koyanagi-Harada Disease
NCT ID: NCT05627739
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
15 participants
OBSERVATIONAL
2021-10-01
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Mycophenolate Mofetil
Glucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid.
traditional therapy group
Patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mycophenolate Mofetil
Glucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaomin Zhang
Principal Investigator, MD, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
xiaomin Zhang
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
xiaomin Zhang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022KY-28
Identifier Type: -
Identifier Source: org_study_id