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Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis | Clinical Trials | Clareo Health

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Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis: A Multicenter, Randomized, Non-inferiority Clinical Trial

NCT06310837•Zhongshan Ophthalmic Center, Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 70 years old ( including boundary value ), male or female.
•2. At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis.
•3. 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.
•4. At least one eye is diagnosed as active uveitis at baseline；
•5. Subject is voluntary to participate in the study and sign the informed consent form.

Exclusion Criteria

•1. Subject with isolated anterior uveitis.
•2. 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).
•3. Subject is suspected or diagnosed as infectious uveitis.
•4. 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.
•5. Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR \> 1.34 or \<20 letters) in the better eye.
•6. Subject with other fundus diseases.
•7. Subject with demyelinating diseases.
•8. Subject has a contraindication to pupil dilation with mydriatic eyedrops.
•9. Subject with corneal or lens opacity that precludes visualization of the anterior segment and fundus.
•10. 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.
+7 more criteria

Locations (1)

Shenzhen Eye Hospital

Shenzhen, Guangdong, China

Key Dates

Start Date

March 27, 2024

Primary Completion Date

October 31, 2025

Completion Date

May 1, 2026

Last Updated

May 23, 2025

Enrollment

128

ACTUAL participants

Conditions

Uveitis

Interventions

Adalimumab Biosimilars Injection

DRUG

Corticosteroid

DRUG

Immunosuppressive Agents

DRUG

A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

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Active Noninfectious Uveitis Affecting the Posterior Segment

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RECRUITINGPHASE3

The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment

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UveitisUveitis, Posterior+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

Inclusion Criteria

Exclusion Criteria

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