JRCT ID: jRCTs011180031
Registered date:25/03/2019
PSL/CYA therapy for early onset of VKH disease
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Vogt-Koyanagi-Harada disease |
Date of first enrollment | 25/04/2014 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | recurrence of uveitis -inflammation of anterior chamber -choroidal fold -SRD |
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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 |
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Age maximum | <= 70age old |
Gender | Both |
Include criteria | 1. 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 criteria | 1. 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
Primary Sponsor | Namba Kenichi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000013373 |
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 |
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 |
knamba@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Hospital |