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UveitisNCT06310837

Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

A study testing Adalimumab Biosimilars Injection, Corticosteroid and Immunosuppressive Agents in people with Uveitis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Uveitis
What is being tested?
Adalimumab Biosimilars Injection, Corticosteroid and Immunosuppressive Agents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteChina
Study dates
27 Mar 2024to 3 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Eye Hospital

    Shenzhen, Guangdong, 518040

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Uveitis
Being tested
Adalimumab Biosimilars Injection, Corticosteroid, Immunosuppressive Agents
Keywords
Uveitis, Corticosteroids, Adalimumab biosimilars
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab Biosimilars InjectionDrug

    Also called Subcutaneous injection of adalimumab biosimilars

    Adalimumab biosimilars: 80 mg was subcutaneously injected for the first time in the first week, and then 40 mg was subcutaneously injected every two weeks from the first week to the 48 th week.

  • CorticosteroidDrug

    Also called Oral corticosteroids

    Patients received no less than 1 mg / kg.d glucocorticoid at week 0, then implemented according to the standard reduction scheme.

  • Immunosuppressive AgentsDrug

    Also called Immunosuppressant

    Mycophenolate mofetil 1g bid for more than 3 months, maintenance dose not less than 0.5g bid

Study groups in NCT06310837
Study groupRoleWhat they receive
ADA+MMF groupExperimentalAdalimumab biosimilars with immunosuppressants therapy
Receives: Drug: Adalimumab Biosimilars Injection; Drug: Immunosuppressive Agents
Corticosteroids+MMF groupActive comparatorCorticosteroids with immunosuppressive therapy；
Receives: Drug: Corticosteroid; Drug: Immunosuppressive Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of ETDRS letter count for BCVA at week 24 from baseline

    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.

    Measured: week 24

Secondary outcomes (12)

  1. Proportion of patients with weight gain at week 24 from baseline

    Patients would be instructed to remove shoes and heavy clothing for measurement, and weight gain is defined as a 5% increase from baseline.

    Measured: week 24

  2. Time of treatment failures

    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.

    Measured: week 24

  3. Number of treatment failures

    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.

    Measured: week 24

  4. Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline

    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)

    Measured: week 24

  5. Change of anterior chamber inflammation at week 24 from baseline

    Change of anterior chamber inflammation assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria.

    Measured: week 24

  6. Change of vitreous opacity at week 24 from baseline

    Change of vitreous opacity assessed by research doctors with slit-lamp according to the International Uveitis Organization ( SUN group ) classification criteria.

    Measured: week 24

  7. Change of the retinal and choroidal inflammation at week 24 from baseline

    Change of the retinal and choroidal inflammation assessed by fluorescein angiography.

    Measured: week 24

  8. Change of the thickness of retina and choroid in macular area at week 24 from baseline

    Change of the thickness of retina and choroid in macular area evaluated by Optical Coherence Tomography (OCT) or Optical Coherence Tomography Angiography (OCTA).

    Measured: week 24

  9. Occurrence of skin abnormalities at the end of study

    The occurrence of skin abnormalities reported by research doctors based on adverse reaction evaluation criteria (CTCAE v5.0).

    Measured: week 48

  10. Occurrence of hypertension at the end of study

    The occurrence of hypertension assessed by electronic blood manometer based on adverse reaction evaluation criteria (CTCAE v5.0).

    Measured: week 48

  11. Occurrence of hyperglycemia at the end of study

    The occurrence of hyperglycemia assessed by venous blood glucose testing based on adverse reaction evaluation criteria (CTCAE v5.0).

    Measured: week 48

  12. Occurrence of active tuberculosis infection at the end of study

    The occurrence of active tuberculosis infection assessed by pulmonary X-ray examination and tuberculosis bacterial T cell detection and evaluated by research doctors.

    Measured: week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start27 Mar 2024
  3. Primary completion31 Dec 2025
  4. Study completion3 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310837
Sponsor's protocol ID
2023KYPJ300
Status last verified
Jul 2026
First submitted
20 Feb 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adalimumab Biosimilars Injection, Corticosteroid and Immunosuppressive Agents in people with Uveitis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of ETDRS letter count for BCVA at week 24 from baseline (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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