Clinical trial NCT05590416: A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Official title: An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vogt-Koyanagi-Harada Disease
Adalimumab
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital

Brief summary: This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease

Detailed description: Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of adalimumab, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with acute VKH divided into two groups: adalimumab therapy group and traditional therapy group.

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 to 70 years of age.
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:

1. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
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.

Primary outcomes:
measure: Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
timeFrame: 24 weeks
measure: Recurrence rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit
timeFrame: 24 weeks
measure: Prednisone exposure
timeFrame: 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References: