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Clinical Trials/JPRN-jRCTs061220030
JPRN-jRCTs061220030
Active, not recruiting
Phase 2

Prospective study of the efficacy and safety of mycophenolate mofetil in patients with noninfectious uveitis and scleritis

Kiuchi Yoshiaki0 sites10 target enrollmentJune 9, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Kiuchi Yoshiaki
Enrollment
10
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kiuchi Yoshiaki

Eligibility Criteria

Inclusion Criteria

  • 1\) Age at the time of consent acquisition is 18 years or older
  • 2\) Patients who can go to the outpatient clinic every 4 to 12 weeks after the start of administration
  • 3\) Patients who have written consent to participate in this study
  • 4\) Non\-infectious uveitis (intermediate, anterior intermediate, posterior, panuveitis) with a history of at least one eye
  • 5\) At least one eye with active eye inflammation for 90 days or more, SUN criteria, over 2 cells in the anterior chamber, over 2 vitreous opacity, retinal choroidal lesions
  • 6\) Patients who are visiting our hospital for at least one of the following.
  • If there is an activity of eye inflammation even after administration of prednisolone, equivalent to 1
  • mg/ kg, for 4 weeks.
  • When the anti\-inflammatory effect is obtained by oral prednisolone treatment equivalent to 0\.5\-1mg/ kg and the relapse of inflammation due to the gradual decrease in oral administration is within 90 days before registration.
  • If oral steroids are more than 10 mg/day are required 90 days before registration.

Exclusion Criteria

  • 1\) Infectious uveitis
  • 2\) Patients who cannot see through the fundus due to binocular cataract, corneal opacity, post\-iris adhesion, etc.
  • 3\) Chronically low intraocular pressure in both eyes, IOP less than 5 mmHg, 3 months
  • 4\) Patients who underwent endovascular surgery within 3 months before the start of administration of this drug.
  • 5\) Patients who received immunosuppressive agents other than steroids within 12 months before the start of administration of this drug.
  • 6\) Patients positive for hepatitis virus and tuberculosis syphilis.
  • 7\) In patients with severe renal disease, serum Cr 1\.5 mg / dL or higher or CKD stage 3b or higher.
  • 8\) Patients with systemic autoimmune disease.
  • 9\) Patients with the following complications, Liver disease, mental illness, seizure and paroxysmal disease, heart disease due to other causes.
  • 10\) Patients who have had serious side effects with immunosuppressants in the past.

Outcomes

Primary Outcomes

Not specified

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