A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorTianjin Medical University
About this trial
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18 to 70 years of age.
Subjects who do not have previous, active or latent tuberculosis (TB).
Subject must have Vogt-Koyanagi-Harada disease less than one month.
Subject who were previously treated with systemic glucocorticoid less than one week.
Disqualifiers
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).
Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
Trial population
VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Adalimumab
DrugAdalimumab 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: adalimumab group1 intervention
Group B: traditional therapy group0 interventions
Trial outcomes
Primary outcomes
1
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Time frame
24 weeks2
Recurrence rate
The recurrence rates in adalimumab treatment group and control group
Time frame
24 weeksSecondary outcomes
1
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit
Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = \< 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = \> 50 cells.
Time frame
24 weeks2
Prednisone exposure
Cumulative prednisone dose and/or mean prednisone dose
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov