Combining corticosteroids with noncorticosteroid therapy for treating VKH
The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
This study is testing whether combining corticosteroids with other treatments can help people with Vogt Koyanagi Harada disease manage their symptoms better and protect their vision.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | prednisone, Adalimumab, Methotrexate |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05120687 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of combining corticosteroids with noncorticosteroid systemic immunomodulatory therapy (NCSIT) for patients with Vogt Koyanagi Harada disease (VKH), an autoimmune condition that can threaten vision. The research aims to determine the optimal dosage and treatment course of this combination therapy, as current treatments often lead to relapses. By utilizing agents like methotrexate and adalimumab, which have shown promise in controlling inflammation, the study seeks to improve patient outcomes and reduce reliance on corticosteroids.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 to 70 diagnosed with VKH who can safely receive prednisone and immunosuppressive therapy.
Not a fit: Patients with other ocular diseases, significant comorbidities, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for VKH patients, potentially reducing relapses and improving vision outcomes.
How similar studies have performed: Previous studies have shown success with similar noncorticosteroid therapies in treating non-infectious uveitis, indicating potential for this approach in VKH.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis is based on Revised International Diagnostic Criteria (Read et al. 2001b). * Age from 12 to 70 years old. * Patients have no contraindication of prednisone and immunosuppressive therapy, as determined by the investigator based on the results of laboratory and physical examinations. * Written informed consent is provided. Exclusion Criteria: * Patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration * History of renal or hepatic insufficiency, heart failure, systemic inflammatory disease or any other condition that, in the opinion of the investigator, would put the patients at risk by participating in the protocol. * History of infectious disease like chronic or active hepatitis B infection, HIV infection, immunodeficiency syndrome, chronic recurring infections, or active tuberculosis. * Female patients who were pregnant or considering becoming pregnant during the study.
Where this trial is running
Guangzhou, Guangdong
- Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Dan Liang
- Email: liangdan@gzzoc.com
- Phone: #86#-87330402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.