the efficacy and safety of mycophenolate mofetil

JRCT ID: jRCTs061220030

Registered date:09/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Noninfectious uveitis and scleritis
• Date of first enrollment: 16/08/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administration of mycophenolate mofetil

Outcome(s)

• Primary Outcome: safety

Secondary Outcome

1) Response rate, Based on the efficacy assessment of the Standardization of Uveitis Nomenclature, SUN, for uveitis and the Standardized grading system for scleritis, oral steroids less than 5 mg/day and betamethasone installation less than 2 times/day
2) Time to control eye inflammation
3) Time to treatment success
4) Percentage of treatment success
5) Changes in corrected visual acuity
6) Changes in intraocular pressure
7) Changes in laser flare value
8) Presence or absence of macular edema
9) Changes in central retina film thickness
10) Changes in vitreous opacity
11) Therapeutic effect in middle / posterior / panuveitis and scleritis
12) Percentage of discontinuation of oral administration due to side effects
13) Percentage of discontinuation of oral administration due to drug intolerance
14) Visually related health-related quality of life

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
Uveitis that chronically requires immunosuppressive agents, Behcet's disease, polyfocal chorioretinitis,
retinal vasculitis, chronic recurrent stage Vogt Koyanagi Harada's disease, sympathetic ophthalmia,
When steroids cannot be used for a long time due to side effects.
7) Patients who fall under any of the following.
male (No need for contraception) / Women who consent to contraception before, during, and after discontinuation of this drug for 6 weeks / Women who are judged to be medically infertile.

Exclude 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.
11) Patients with malignant disease.
12) Patients who fall under the contraindications for MMF.
13) Patients who fall under at least one of the following.
White blood cells less than 2500 / uL, Platelets less than 75000 / uL, hemoglobin less than 9g / dL,
AST / ALT is more than twice the normal upper limit, Creatinine more than 1.5mg / dL
14) Pregnant or lactating females, females who may be pregnant or who wish to have children.
15) Patients who are participating in or willing to participate in other clinical studies while participating in this study.
16) When it is determined that it interferes with, limits, or confuses the evaluation specific to the clinical research plan.
17) Employees of the investigator or the implementing medical institution that are directly
involved in this research or other clinical research, or the family of such employees or the investigator.

Related Information

• Primary Sponsor: Chikama Taiichiro
• Secondary Sponsor: Hiyama Tomona