NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs011180031

Registered date:25/03/2019

PSL/CYA therapy for early onset of VKH disease

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedVogt-Koyanagi-Harada disease
Date of first enrollment25/04/2014
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)arm mPSL: mPSL (1000mg) given on day 1-3, and then oral PSL gradually decreasing from 40mg/day arm mPSL+CYA: with the above-therapy, CYA (3mg/kg/day) given from day 4

Outcome(s)

Primary Outcomerecurrence of uveitis -inflammation of anterior chamber -choroidal fold -SRD
Secondary Outcome-frequency of side effects -period from the start of therapy to the disappearance of inflammatory findings

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
GenderBoth
Include criteria1. Early onset of Vogt-Koyanagi-Harada (VKH) disease with all of a)-d) a) within 4 weeks from onset b) anterior chamber cells less than or equal to 2+ c) with typical serous retinal detachment (SRD) d) without sunset glow fundus 2. Complete or Incomplete type of VKH disease 3. Presence of cerebrospinal fluid pleocytosis or meningeal irritating sign except for headache 4. Able to receive treatment within 4 weeks from onset 5. Written informed consent
Exclude criteria1. Renal dysfunction 2. Receiving immunosuppressant or corticosteroid therapy 3. State of immunosuppression 4. Pregnant, unwilling to practice contraception during the study, or lactating female 5. Malignant tumor 6. Intraocular surgery (except for cataract surgery) or glaucoma surgery in the past or future

Related Information

Contact

Public contact
Name Kayo Suzuki
Address Department of Ophthalmology Faculty of Medicine and Graduate School of Medicine, Hokkaido University N-15, W-7, Kita-ku, Sapporo Hokkaido Japan 060-8638
Telephone +81-11-706-5944
E-mail ksuzuki@med.hokudai.ac.jp
Affiliation Hokkaido University Hospital
Scientific contact
Name Kenichi Namba
Address Department of Ophthalmology Faculty of Medicine and Graduate School of Medicine, Hokkaido University N-15, W-7, Kita-ku, Sapporo Hokkaido Japan 060-8638
Telephone +81-11-706-5944
E-mail knamba@med.hokudai.ac.jp
Affiliation Hokkaido University Hospital