The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease.

UMIN ID: UMIN000017093

Registered date:10/04/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Vogt-Koyanagi-Harada disease
• Date of first enrollment: 2014/04/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1.The group given only prednisolone mPSL 1000mg Intravenous Infusion 3 days PSL 0.6-0.7mg/kg Oral Administrarion 10 days PSL 0.5-0.6mg/kg Oral Administrarion 10 days PSL 0.4-0.5mg/kg Oral Administrarion 10 days PSL 0.3-0.4mg/kg Oral Administrarion 4 weeks PSL 0.2-0.3mg/kg Oral Administrarion 4 weeks PSL 0.1-0.2mg/kg Oral Administrarion 4 weeks PSL 0.05-0.1mg/kg Oral Administrarion 8 weeks PSL 0.05-0.1mg/kg every other day Oral Administrarion 4 weeks
2.The group given combination of prednisolone and cyclosporine In addition to "1.",CYA 3mg/kg is administered from day 4

Outcome(s)

• Primary Outcome: Proportion of subjects showing recurrences of uveitis with VKH disease

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1.Renal dysfunction 2.Immunosuppressant treatment including steroid 3.Immunocompromised condition 4.Females who are pregnant or lactating patients or who are suspicious of pregnant 5.Malignant neoplasm 6.Ontraocular surgery (except for cataract surgery) or glaucoma surgery previously,or speculate to be required in the periods of this study 7.Investigator declare a subject ineligible for any sound reasons

Related Information

• Primary Sponsor: University of Tokyo Graduate School of Medicine
• Source(s) of Monetary Support: University of Tokyo Graduate School of Medicine