Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH

  • STATUS
    Recruiting
  • End date
    Oct 6, 2025
  • participants needed
    200
  • sponsor
    Sun Yat-sen University
Updated on 25 November 2021
corticosteroids
cyclophosphamide
methotrexate
prednisone
adalimumab
mycophenolate
vogt
Accepts healthy volunteers

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).

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- 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.

Details
Condition Uveitis, harada, vogt-koyanagi-harada disease, Vogt-Koyanagi-Harada Syndrome
Treatment noncorticosteroid systemic immunomodulatory therapy (NCSIT)
Clinical Study IdentifierNCT05120687
SponsorSun Yat-sen University
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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