Phase
Condition
Uveitis
Treatment
Immunosuppressive Agents
Adalimumab Biosimilars Injection
Corticosteroid
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 70 years old ( including boundary value ), male or female.
At least one eye is diagnosed as noninfectious intermediate uveitis, posterioruveitis or panuveitis.
Subject is on prednisone ≥ 10 mg/day (or corticosteroid equivalent) for at least 2weeks prior to Screening and remains on the same dose from screening to baselinevisit.
At least one eye is diagnosed as active uveitis at baseline;
Subject is voluntary to participate in the study and sign the informed consent form.
Exclusion
Exclusion Criteria:
Subject with isolated anterior uveitis.
Subject with prior inadequate response to or intolerance to high-dosecorticosteroids (equivalent of prednisone 1 mg/kg/day or 60 to 80 mg/day).
Subject is suspected or diagnosed as infectious uveitis.
Uncontrolled glaucoma or high intraocular pressure, defined as intraocularpressure>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence ofglaucomatous optic nerve injury.
Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR > 1.34) in the better eye.
Subject with other fundus diseases.
Subject with demyelinating diseases.
Subject has a contraindication to pupil dilation with mydriatic eyedrops.
Subject with corneal or lens opacity that precludes visualization of the anteriorsegment and fundus.
Topical corticosteroids and/or topical NSAID>3 drops per day in the 14 days prior tobaseline; Dexamethasone/betamethasone or equivalent subconjunctival steroid within 30 days prior to baseline; Parafbulbar, intravitreal (IVT), suprasoroidal, orperiocular corticosteroid injections were administered within 60 days prior tobaseline; Received IVT anti-VEGF therapies less than 60 days prior to baseline;Dexamethasone (Ozurdex) IVT implant within 6 months prior to baseline; Fluocinoloneacetonide IVT implant within 3 years prior to baseline.
Subject with history of prior intraocular surgery within 90 days prior to baselineor any planned (elective) eye surgery within the next 1 year from baseline.
Subject is diagnosised or suspected tuberculosis, hepatitis B virus, hepatitis Cvirus, HIV, syphilis infection or with other uncontrolled active infections or otherinfections that would put the subject at uncontrolled risk.
Subject with severe, progressive, or uncontrolled symptoms of renal, hepatic,hematologic, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebraldiseases or with malignant tumors or with moderate to severe heart failure andsubjects who are considered by the investigator to be at unacceptable risk byparticipating in the study.
Prior biologic and immunosuppressant therapy other than corticosteroids at any time.
Subject with a systemic inflammatory disease that requires continued therapy withoral corticosteroids or a prohibited immunosuppressive agent at Screening orBaseline visits.
Fertile woman who has a positive serum pregnancy test at the screening visit orplans for pregnancy and sperm donation during the trial and within 6 months afterthe end of the study.
Other subjects who are considered by the investigator to be inappropriated forenrollment.
Study Design
Study Description
Connect with a study center
Zhongshan Ophthalmic Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
Shenzhen Eye Hospital
Shenzhen, Guangdong 518040
ChinaActive - Recruiting
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