Clinical trial NCT05120687: Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
Official title: The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vogt Koyanagi Harada Disease (VKH)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VKH patients treated at Zhongshan Ophthalmic Center between October 2021 and October 2025.

Brief summary: The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).

Detailed description: Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse.

Noncorticosteroid systemic immunomodulatory therapy (NCSIT) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. Methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. Adalimumab, humanized monoclonal anti-TNF-α antibody, have demonstrated the efficacy of noninfectious uveitis. Several randomized controlled trials have proved the efficacy and safety of NCSIT such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown.

The investigators propose to explore the effect, safety and optimal dose of prednisone combining NCSIT in the treatment of VKH.

Eligibility 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.

Primary outcomes:
measure: Number of participants achieving corticosteroid-sparing effect
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References: