Assessment of Safety , Clinical Efficacy with QLETLI in Non-infectious Uveitis (UV)

Inclusion Criteria:

• Patients voluntarily participated in the study and signed informed consent

• Aged between 18 and 70 (including threshold), male or female;

• Diagnosis of non-infectious intermediate, posterior, or total uveitis in at leastone eye;

• Received maintenance therapy (oral prednisone 10-60mg/day or equivalentglucocorticoid for ≧2 weeks before screening, and no dose adjustment from screeningto baseline;

• At baseline, at least one eye was diagnosed with active uveitis, presenting asmeeting at least one of the following criteria: active inflammatory chorioretinaland/or inflammatory retinal vasculopathy; Cell grade of anterior chamber ≧2+; Degreeof vitreous turbid ≧2+;

• Negative serum pregnancy test results of women of childbearing age during screeningvisits;

Exclusion Criteria:

• Patients with the following eye conditions:

• Patients with simple anterior uveitis;

• Uveitis with macular edema as the only manifestation;

• is confirmed or suspected infectious uveitis (including but not limited to thefollowing causes of infectious uveitis, tuberculosis, cytomegalovirus, lyme disease,toxoplasmosis, human, T, Whipple's disease virus type 1 infection, herpes zostervirus and herpes simplex virus) or disguise syndrome (for example: eye trauma,lymphoma, malignant tumor, or surgery, etc.);

• Uncontrolled glaucoma, defined as intraocular pressure higher than 25 mmHg afterdrug treatment, or optic nerve damage;

• Best corrected visual acuity of less than 20 letters in at least one eye atbaseline;

• With other fundus diseases (such as fertile or serious non fertile diabeticretinopathy or diabetic retinopathy with clinical significance of macular edema,retinal vein occlusion, macular degeneration, age, sex, blood vessel patternschange, the pathological myopia, retinal detachment, macular hole, toxoplasmosis,optic nerve disease, etc.);

• Demyelinating disease (including myelitis and optic neuritis) or a history ofneurology suggesting symptoms of demyelinating disease (including but not limited tooptic neuritis);

• Refractive media opacity or pupil failure that significantly interferes with visualacuity detection, anterior segment and fundus assessment;

• One-eyed patients deemed unsuitable for inclusion by the investigator;

• Peribulbar, intravitreal or subocular corticosteroid injections were given within 30days prior to screening;

• Posterior capsulotomy was performed within 30 days prior to screening;

• Cataract surgery is expected within 90 days prior to screening or during the studyperiod;

• An intravitreal injection of anti-VEGF therapy (e.g., raizumab, apecivir, orCombocept) within 90 days prior to baseline;

• Ozurdex implants (dexamethasone implants) were performed within 6 months prior tobaseline;

• Treatment with intravitreal injection of methotrexate within 90 days prior tobaseline;

• Had been treated with vitreous Retisert (glucocorticoid implant) or hadcomplications with the implant during the 36 months prior to baseline; Removal ofRetisert within 90 days prior to baseline or complications of removal.

• Having any of the following general conditions:

• Subjects meet any of the following criteria associated with latent or activetuberculosis (TB) infection:

. A history of active TB ≤ 3 years before screening (but can also be included if itis > 3 years and documented completion of adequate treatment); B. Signs or symptomssuggestive of active TB at the time of screening in the history and/or physicalexamination; C. Recent close contact with someone with active TB; D. If a TBinfection T-cell test is positive at the time of screening, subjects will beexcluded from the study if their first TB infection T-cell test is inconclusive. Forsuitable standards has been completed before screening latent TB treatment and noother risk factors, imaging findings, or support the latent or signs of active TBspecific subjects, for positive or uncertain results may be the exception handling,researchers with the qualified physician judgment, tuberculosis (includingextrapulmonary) risk, decision and discuss with bidders;

• Positive hepatitis C antibody during screening; Or HIV antibody positive; Ortreponema pallidum antibody positive;

• Symptoms of severe, progressive or uncontrollable kidney, liver, blood,gastrointestinal, lung, cardiovascular, neurological or brain disease. Theinvestigator felt that participating in the study placed patients at unacceptablerisk.

• Patients with malignant tumors.

• Patients with moderate to severe heart failure (New York Heart Society Grades 3-4).

• History of severe allergy or anaphylactoid reaction to monoclonal antibodies.

• Prior treatment with anti-TUMOR necrosis factor TNF or other biological agents withpotential therapeutic effect for uveitis (excluding intravitreal anti-VEGF drugs).

• During the 30 days prior to baseline, the combined dose of other immunosuppressanttherapy increased or did not meet any of the following conditions: methotrexateMTX≤25mg/ week; Cyclosporine ≤4 mg/kg/ day; Mycophenolate (or equivalent dose ofmycophenolate) ≤2g/ day; Azathioprine ≤175 mg/ day; Tacrolimus oral ≤8 mg/ day.

• Received clinical trial drug intervention within 3 months prior to screening.

• Received any live vaccine within 3 months prior to receiving the first dose of thestudy drug, or planned to receive live vaccine during the study period.

• There are contraindications to dilatation drugs.

• Patients judged unsuitable for inclusion by other investigators