Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

Last updated: June 4, 2024
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uveitis

Treatment

Immunosuppressive Agents

Adalimumab Biosimilars Injection

Corticosteroid

Clinical Study ID

NCT06310837
2023KYPJ300
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, posterioruveitis or panuveitis.

  3. 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.

  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

Exclusion Criteria:

  1. Subject with isolated anterior uveitis.

  2. Subject with prior inadequate response to or intolerance to high-dosecorticosteroids (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 intraocularpressure>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence ofglaucomatous optic nerve injury.

  5. Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR > 1.34) 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 anteriorsegment and fundus.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Prior biologic and immunosuppressant therapy other than corticosteroids at any time.

  15. Subject with a systemic inflammatory disease that requires continued therapy withoral corticosteroids or a prohibited immunosuppressive agent at Screening orBaseline visits.

  16. 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.

  17. Other subjects who are considered by the investigator to be inappropriated forenrollment.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Immunosuppressive Agents
Phase:
Study Start date:
March 27, 2024
Estimated Completion Date:
September 27, 2025

Study 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.

Connect with a study center

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Shenzhen Eye Hospital

    Shenzhen, Guangdong 518040
    China

    Active - Recruiting

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