Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH

Recruiting

• Conditions: Vogt Koyanagi Harada Disease (VKH)
• Interventions: Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT)

• Registration Number: NCT05120687
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-15
• Last Update Posted: 2021-11-15
• Primary Completion: 2024-10-06
• Study Completion: 2025-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corticosteroid + NCSIT group	noncorticosteroid systemic immunomodulatory therapy (NCSIT)	Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide.

Primary Outcome Measures

Name	Time	Method
Number of participants achieving corticosteroid-sparing effect	6 months	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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China