A Study of Mycophenolate Mofetil Combined With Glucocorticoid Therapy in Relapse Vogt-Koyanagi-Harada Disease

NCT05627739 | Unknown

• 1 other identifier: 2022KY-28
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease

Conditions

Vogt-Koyanagi-Harada Disease; Mycophenolate Mofetil

Outcome Measures

Primary Outcomes (2)

• Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.

  The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.

  24 weeks

• Recurrence rate

  The recurrence rates in Mycophenolate mofetil treatment group and control group

  24 weeks

Secondary Outcomes (2)

• Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit

  24 weeks

• Prednisone exposure

  12 months

Study Arms (2)

Mycophenolate Mofetil therapy Group

An initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day.

Drug: Mycophenolate Mofetil

traditional therapy group

Patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine.

Interventions

Mycophenolate Mofetil DRUG

Glucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid.

Mycophenolate Mofetil therapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital

You may qualify if:

• Subject is 18 to 70 years of age.
• Subjects who do not have previous, active or latent tuberculosis (TB).
• Subject must start Vogt-Koyanagi-Harada disease more than two months, and develop at least one recurrence.

You may not qualify if:

• Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
• Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
• Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor \[VEGF\] therapy) with a potential therapeutic impact on non-infectious uveitis.
• Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
• Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
• Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

xiaomin Zhang

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

xiaomin Zhang

CONTACT

+8613920023990; xiaomzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 28, 2022
• Study Start: October 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

CN (1)