Scleritis inflammation of sclera
Conditions
Interventions
Perform examinations and treatments in the following order.
(1) Steroid eye drops (betamethasone sodium phosphate eye drops)
1-2 drops at a time, 4 or more times a day (up to 8 times a day) for up to
D001623, D008727
steroid eye drop, methotrexate
Sponsors
Matsumiya Wataru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged between 18 and 70 at the time of informed consent (2) Patients with active inflammation in the sclera Patients with idiopathic non-necrotizing scleritis with a scleritis score of 1 or higher who have a history of steroid eye drops for 2 weeks or more and subsequently have recurrence or prolonged inflammation (3) Males and females who agree to use contraception before and during administration of this drug and for 3 months after discontinuation of this drug, or males and females who are medically judged to be infertile (4) Patients who have shown the consent of agreement with the written informed consent by their own free will after receiving a sufficient explanation for participating in this study.
Exclusion criteria
Exclusion criteria: Patients who correspond to any of the following are excluded from the study. 1. Patients with only posterior or episcleritis of scleritis 2. Patients with infectious scleritis 3. Patients with severe renal dysfunction (judged by following states) Patients receiving dialysis or glomerular filtration rate (GFR) 60 (U/L) or ALT>84 (U/L) (2) Complication of acute/chronic active viral hepatitis B or C (3) Liver cirrhosis (4) Other severe liver dysfunction. 12. Patients with severe respiratory disorders (refer to the following criteria for judgment) (1) Presence of hypoxemia SpO2<93% in room air (equivalent to PaO2<70 Torr) (2) Restrictive disorder with % VC < 80% in pulmonary function test (3) Presence of advanced pulmonary fibrosis in chest X-ray imaging 13. Patients with severe infections 14.In addition to the above, the drug is contraindicated for target diseases (systemic diseases: myelosuppression, pleural effusion, ascites. ocular diseases: corneal epithelial erosion or ulcer, viral conjunctival corneal disease, tuberculous eye disease, fungal eye disease, or purulent eye disease, ocular tuberculosis.) 15. Other patients who are judged to be inappropriate as research subjects by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success at 24 weeks after protocol treatment Definition: Treatment success: Treatment success is defined as the fulfillment of the following two items 1 Based on the standardized grading system for scleritis, scleritis score, transition to inactivity, scleritis score 0 or 0.5, with betamethasone instillation less than or equal 2 times per day without recurrence after starting the study drug administration 2 Not receiving rescue therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation items Treatment success at 36 weeks and 48 weeks Time to treatment success Score by Standardized grading system for scleritis (at each time point of 2, 4, 8, 16, 20, 24, 36, 48 weeks) Definitions: At each visit, a 4-quadrant (nasal, temporal, superior, and inferior) anterior segment photo is performed, and the scleritis score is determined by the attending physician based on the images. Judgment adopts the scleritis score of the most severe quadrant. At the end of the study, the obtained images are masked before and after and scored by a third party (scleritis score) to confirm the rate of agreement with the clinical judgment of the attending physician. Modified treatment success at 24, 36, and 48 weeks Definition: Modified treatment success: Scleritis is improved to inactive (scleritis score 0 or 0.5) and maintained with oral sterodi less than or equal 7.5 mg per day or betamethasone instillation less than or equal 2 times per day after starting the study drug administration Time to modified treatment success Course of anterior chamber inflammation (cell and flare) according to Standardization of Uveitis Nomenclature (SUN) classification (at each time point of 0, 2, 4, 8, 16, 20, 24, 36, 48 weeks) Presence or absence of posterior eye inflammation Course (haze) of vitreous inflammation according to the Standardization of Uveitis Nomenclature (SUN) classification when posterior segment inflammation occurs (at each time point of 0, 2, 4, 8, 16, 20, 24, 36, 48 weeks) Presence or absence of rescue treatment With rescue treatment Type of rescue treatment Reason for rescue (recurrence/number of treatment-resistant cases/others) Time from initiation of treatment (day 1) to need of rescue treatment Time from initiation of rescue treatment to remission Presence or absence of adjuvant therapy, the content of adjuvant therapy, number of times of adjuvant therapy Definition: Recurrence: Cases where the score by the Standardized grading system for scleritis | — |
Contacts
Public ContactRei Sotani
Kobe university hospital
Outcome results
None listed