Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
- Conditions
- Uveitis
- Interventions
- Registration Number
- NCT06310837
- Brief Summary
This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues.
- Detailed Description
The study will be followed up in the screening-baseline period and at 4,8,12,18,24,36, and 48 weeks after the start of the study drug. The ETDRS letter number change of the best corrected visual acuity ( BCVA ) at 24 weeks compared with the baseline was used as the main indicator. The last follow-up was performed at 48 weeks.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- Age 18 to 70 years old ( including boundary value ), male or female.
- At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis.
- Subject is on prednisone ≥ 10 mg/day (or corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from screening to baseline visit.
- 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.
- Subject with isolated anterior uveitis.
- Subject with prior inadequate response to or intolerance to high-dose corticosteroids (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 intraocular pressure>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence of glaucomatous optic nerve injury.
- Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR > 1.34 or <20 letters) 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 anterior segment and fundus.
- Topical corticosteroids and/or topical NSAID>3 drops per day in the 14 days prior to baseline; Dexamethasone/betamethasone or equivalent subconjunctival steroid within 30 days prior to baseline; Parafbulbar, intravitreal (IVT), suprasoroidal, or periocular corticosteroid injections were administered within 60 days prior to baseline; Received IVT anti-VEGF therapies less than 60 days prior to baseline; Dexamethasone (Ozurdex) IVT implant within 6 months prior to baseline; Fluocinolone acetonide IVT implant within 3 years prior to baseline.
- Subject with history of prior intraocular surgery within 90 days prior to baseline or any planned (elective) eye surgery within the next 1 year from baseline.
- Subject is diagnosised or suspected tuberculosis, hepatitis B virus, hepatitis C virus, HIV, syphilis infection or with other uncontrolled active infections or other infections that would put the subject at uncontrolled risk.
- Subject with severe, progressive, or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral diseases or with malignant tumors or with moderate to severe heart failure and subjects who are considered by the investigator to be at unacceptable risk by participating in the study.
- Prior biologic and immunosuppressant therapy other than corticosteroids at any time.
- Subject with a systemic inflammatory disease that requires continued therapy with oral corticosteroids or a prohibited immunosuppressive agent at Screening or Baseline visits.
- Fertile woman who has a positive serum pregnancy test at the screening visit or plans for pregnancy and sperm donation during the trial and within 6 months after the end of the study.
- Other subjects who are considered by the investigator to be inappropriated for enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADA+MMF group Adalimumab Biosimilars Injection Adalimumab biosimilars with immunosuppressants therapy ADA+MMF group Immunosuppressive Agents Adalimumab biosimilars with immunosuppressants therapy Corticosteroids+MMF group Immunosuppressive Agents Corticosteroids with immunosuppressive therapy； Corticosteroids+MMF group Corticosteroid Corticosteroids with immunosuppressive therapy；
- Primary Outcome Measures
Name Time Method Change of ETDRS letter count for BCVA at week 24 from baseline week 24 The best corrected visual acuity of the patient would be examined by the ETDRS visual acuity chart according to the visual acuity examination SOP. Change of ETDRS letter count for BCVA at week 24 from baseline were the main indicator, the outcome at other follow-up time points（Baseline, weeks 4, 8, 12, 18, 36, 48）would also be included in the outcome analysis.
- Secondary Outcome Measures
Name Time Method Occurrence of hyperglycemia at the end of study week 48 The occurrence of hyperglycemia assessed by venous blood glucose testing based on adverse reaction evaluation criteria (CTCAE v5.0).
Number of treatment failures week 24 Treatment failure is defined as an increase in the degree of inflammation in one or more of four areas, including choroidal and/or retinal vasculopathy, macular edema, anterior chamber cell grade, and vitreous opacity grade, assessed by the investigators from week 4 to the end of follow-up.
Occurrence of skin abnormalities at the end of study week 48 The occurrence of skin abnormalities reported by research doctors based on adverse reaction evaluation criteria (CTCAE v5.0).
Time of treatment failures week 24 Treatment failure is defined as an increase in the degree of inflammation in one or more of four areas, including choroidal and/or retinal vasculopathy, macular edema, anterior chamber cell grade, and vitreous opacity grade, assessed by the investigators from week 4 to the end of follow-up.
Proportion of patients with weight gain at week 24 from baseline week 24 Patients would be instructed to remove shoes and heavy clothing for measurement, and weight gain is defined as a 5% increase from baseline.
Change of vitreous opacity at week 24 from baseline week 24 Change of vitreous opacity assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria.
Occurrence of active tuberculosis infection at the end of study week 48 The occurrence of active tuberculosis infection assessed by pulmonary X-ray examination and tuberculosis bacterial T cell detection and evaluated by research doctors.
Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline week 24 The changes of each follow-up time point from the baseline are evaluated according to VFQ-25 visual function evaluation scale.To calculate an overall composite score for the VFQ-25, we will simply average the vision-targeted subscale scores, excluding the general health rating question.(100=best, 0=worst possible score)
Change of anterior chamber inflammation at week 24 from baseline week 24 Change of anterior chamber inflammation assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria.
Change of the retinal and choroidal inflammation at week 24 from baseline week 24 Change of the retinal and choroidal inflammation assessed by fluorescein angiography.
Occurrence of hypertension at the end of study week 48 The occurrence of hypertension assessed by electronic blood manometer based on adverse reaction evaluation criteria (CTCAE v5.0).
Change of the thickness of retina and choroid in macular area at week 24 from baseline week 24 Change of the thickness of retina and choroid in macular area evaluated by Optical Coherence Tomography (OCT) or Optical Coherence Tomography Angiography (OCTA).
Trial Locations
- Locations (1)
Shenzhen Eye Hospital
🇨🇳Shenzhen, Guangdong, China