refractory non-infectious uveitis
Conditions
Interventions
Control group:Traditional therapy plus a matching placebo tablet identical in size, appearance, and odor.
"Traditional therapy" is defined as the permitted use of any one or any combination of the fol
Treatment group:Traditional therapy plus dapagliflozin 10 mg once daily
"traditional therapy" is defined as the permitted use of any one or any combination of the following:
a. oral corticosteroids (=4 weeks before enrollment and must not be increased, decreased, or switc
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Determined by a specialist doctor to meet the diagnostic criteria for refractory non-infectious uveitis: The anatomical classification was posterior/total uveitis, with OCT-CRT=300 µm and cystoid macular edema. After excluding the nature of infection (referring to the criteria of the Journal of the American Medical Association) and tumor nature (such as intraocular lymphoma, retinoblastoma), there was still definite active inflammation after treatment with adequate glucocorticoids and/or =1 conventional immunosuppressant for =4 weeks. Further additional or upgraded treatment is required. 2. Age: 18 to 65 years old, gender not limited. 3. Intraocular pressure of 5 to 25 mmHg and clear refractive media are sufficient to obtain high-quality OCT. 4. Good renal function: eGFR > 45 mL·min·1.73 m², no history of kidney disease, hypotension or hypoglycemia. 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of glaucoma or ocular hypertension (including prior anti-glaucoma surgery or laser). 2. Intraocular pressure > 25 mmHg at enrollment or poorly controlled glaucoma (requiring >=2 IOP-lowering drugs or IOP still above target). 3. Advanced glaucomatous optic-nerve damage (cup-to-disc ratio =0.8 or visual-field MD 0.6 (Snellen 20/30). 8. Any infectious uveitis (per SUN 2021 infection screening list and JAMA Infectious Uveitis criteria). 9. Planned elective intraocular or ocular-surface surgery during the study (including cataract, vitrectomy, or anti-glaucoma procedures). 10. Current use of loop/thiazide diuretics, or ongoing dialysis, planned or prior renal transplantation. 11. Multiple cardiovascular risk factors with eGFR =9 %. 12. AIDS, primary immunodeficiency, or any medically judged immunosuppressive state contraindicating systemic corticosteroids. 13. Previous anaphylaxis, angioedema, or serious cutaneous adverse reactions related to SGLT2 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of reducing inflammation activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thickness, CRT;vision;Anterior chamber cells; | — |
Countries
China
Contacts
Public ContactWenru Su
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed