PSL/CYA therapy for early onset of VKH disease

Phase 3

• Conditions: Vogt-Koyanagi-Harada disease

• Registration Number: JPRN-jRCTs011180031
• Lead Sponsor: amba Kenichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence of uveitis<br>-inflammation of anterior chamber<br>-choroidal fold<br>-SRD

Secondary Outcome Measures

Name	Time	Method
-frequency of side effects<br>-period from the start of therapy to the disappearance of inflammatory findings