A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
NCT ID: NCT05590416
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2021-06-01
2024-12-30
Brief Summary
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Detailed Description
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For adalimumab therapy group, an initial dose of 80 mg adalimumab was administered subcutaneously followed by a maintenance dose of 40 mg every two weeks, and data will be collected prospectively with regard to ophthalmologic outcomes. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to one year to determine efficacy and side effects.
According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of adalimumab in treatment of acute VKH.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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adalimumab group
The initial dose of glucocorticoid is 1 mg/kg/day, and gradually stops within 90-180 days. Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.
Adalimumab
Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.
traditional therapy group
Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents.
No interventions assigned to this group
Interventions
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Adalimumab
Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who do not have previous, active or latent tuberculosis (TB).
3. Subject must have Vogt-Koyanagi-Harada disease less than one month.
4. Subject who were previously treated with systemic glucocorticoid less than one week.
5. Subject meets at least 1 of the following criteria:
1)patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).
Exclusion Criteria
2. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
3. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
4. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
5. Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
6. Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
18 Years
70 Years
ALL
No
Sponsors
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Tianjin Medical University
OTHER
Responsible Party
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Xiaomin Zhang
Principal Investigator, MD, PhD
Locations
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Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022KY-16
Identifier Type: -
Identifier Source: org_study_id
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