Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH

N/AUnknownNCT05120687

Sun Yat-sen University200 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Vogt Koyanagi Harada Disease (VKH)

Interventions

noncorticosteroid systemic immunomodulatory therapy (NCSIT)DRUG

Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Number of participants achieving corticosteroid-sparing effect

Corticosteroid-sparing effect is defined by the following: (1) less than or equal to 0.5+ anterior chamber cells, less than or equal to 0.5+ vitreous haze and no active retinal or choroidal lesions; (2) no more than 10 mg of oral prednisone per day; (3) all the above-mentioned description should be maintained over 1 month

Time frame: 6 months

Central Contacts

Dan Liang

CONTACT

#86#-87330402 liangdan@gzzoc.com

Data from ClinicalTrials.gov

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