Non-infectious uveitis
Conditions
Interventions
Test group:Corticosteroids + Adalimumab
Control group:Corticosteroids + Immunosuppressants
Sponsors
Shenzhen Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years (inclusive), male or female; 2. Diagnosed with non-infectious intermediate, posterior, or panuveitis in at least one eye; 3. Have received systemic corticosteroid therapy with prednisone >=10 mg/day (or an equivalent oral dose of corticosteroids) for at least 2 consecutive weeks prior to baseline, and maintain the same dose from the screening period to baseline; 4. At least one eye diagnosed with active uveitis at baseline, with active manifestations meeting at least one of the following: active inflammatory chorioretinal or inflammatory retinal vascular lesions; macular edema shown by optical coherence tomography (OCT) with evidence of intraocular inflammation; anterior chamber cell grade >=2+ (SUN grading); vitreous haze grade >=2+ (SUN grading); 5. Voluntarily join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Ocular Exclusion Criteria (Patients with any of the following ocular conditions): 1. Patients with simple anterior uveitis; 2. Subjects with a history of inadequate response or intolerance to high-dose corticosteroids (equivalent to prednisone 1 mg/kg/day or 60–80 mg/day); 3. Suspected or confirmed infectious uveitis (including but not limited to infectious uveitis caused by tuberculosis, cytomegalovirus, toxoplasmosis, human T-lymphotropic virus type 1 infection, varicella-zoster virus, or herpes simplex virus); or masquerade syndrome (e.g., lymphoma, ocular malignancy, etc.); 4. Presence of uncontrolled glaucoma or ocular hypertension, defined as intraocular pressure >25 mmHg despite treatment with >=2 anti-glaucoma medications, or evidence of glaucomatous optic nerve damage; 5. Best-corrected visual acuity in the better-seeing eye 1.34), or monocular patients deemed unsuitable for study enrollment by the investigator; 6. Presence of other concomitant fundus diseases (e.g., proliferative or severe non-proliferative diabetic retinopathy, retinal vein occlusion secondary to diabetic retinopathy, age-related macular degeneration, angioid streaks, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.); 7. Concomitant demyelinating disease (including myelitis and optic neuritis) or neurological history suggestive of demyelinating disease symptoms (including but not limited to optic neuritis); 8. Inability to achieve adequate pupillary dilation; 9. Corneal or lens opacities that significantly interfere with anterior segment and fundus evaluation; 10. Use of topical ocular corticosteroids and/or topical ocular NSAIDs >3 drops/day within 14 days prior to baseline (i.e., 3 years with documented adequate treatment completion); b. Signs or symptoms suggestive of active TB based on medical history and/or physical examination during screening; c. Recent close contact with a person with active TB; d. Positive T-SPOT.TB test result or indeterminate result on initial T-SPOT.TB test at screening – such subjects will be excluded from the study. Exceptions may apply for subjects with positive or indeterminate results who have completed appropriate standard treatment for latent TB prior to screening and have no other risk factors, imaging findings, or specific signs supporting latent or active TB (to be determined by the investigator in consultation with a qualified infectious
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in best-corrected visual acuity (BCVA) from baseline in ETDRS letter score at week 24 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| At week 24, the proportion of weight gain, where weight gain is defined as a 5% increase in body weight from baseline; | — |
Countries
China
Contacts
Public ContactWei Chi
Shenzhen Eye Hospital
Outcome results
None listed