A study on combination therapy of methotrexate and steroid eye drops for scleritis

Not Applicable

Recruiting

• Conditions: Scleritis; inflammation of sclera; D015423

• Registration Number: JPRN-jRCTs051230023
• Lead Sponsor: Matsumiya Wataru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-19
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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) <30 mL/min/1.73m2
4. Patients already taking immunosuppressants or corticosteroids at the time of enrollment
5. Patients who appear to be immunosuppressed (e.g., congenital immune deficiency, HIV infection, etc)
6. Patients who are pregnant, lactating, or may be pregnant
7. Patients with malignant tumors
8. Patients who have undergone intraocular surgery or glaucoma surgery in the past, excluding cataract surgery, or who are expected to require surgery during this clinical study
9. Patients who have a history of hypersensitivity to methotrexate or betamethasone eye drop
10. Patients with significant hematological/lymphatic disorders
(1) Patients have a history of myelodysplastic syndrome, aplastic anemia, or blood-cell aplasia
(2) Patients have been diagnosed or treated for lymphoproliferative disease within the past 5 years
(3) Patients with leukopenia or thrombocytopenia: following criteria should be used for the judgment, and the presence of other complications should be also considered: 1) White blood cell count < 3,000/mm3, 2) Platelet count < 50,000/mm3
11. Patients with liver dysfunction
(1) Hepatic dysfunction AST>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

Study & Design

• Study Type: Interventional
• Study Design: Not specified