Actively Recruiting
An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
Led by Tianjin Medical University · Updated on 2024-07-03
15
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adalimumab for patients with acute Vogt-Koyanagi-Harada (VKH) disease to test if it provides clinical benefits. This observational study divides participants into two groups: one receiving adalimumab therapy and the other receiving traditional treatment with glucocorticoids alone or combined with immunosuppressants. The study follows ethical guidelines and informed consent was obtained from all patients. In the adalimumab group, patients receive an initial subcutaneous dose of 80 mg, then 40 mg every two weeks. Therapy continues for six months after ocular inflammation subsides, followed by tapered injections until withdrawal after 40 days. The traditional therapy group follows glucocorticoid treatment starting at 1 mg/kg/day, gradually stopped over 90 to 180 days. The study lasts up to one year to track treatment outcomes and side effects. Participants undergo regular assessments including best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), and corticosteroid dose changes. Researchers monitor anti-inflammatory and immunosuppressive effects of adalimumab, visual acuity changes, and recurrence rate at 24 weeks. Prednisone exposure is also tracked over 12 months to evaluate treatment impact and safety throughout the study period.
CONDITIONS
Brief Title
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- No previous, active or latent tuberculosis (TB)
- Diagnosis of Vogt-Koyanagi-Harada disease for less than one month
- Systemic glucocorticoid treatment for less than one week prior to study
- Meets at least one: refuses systemic glucocorticoids due to side effects, has high-risk or systemic disease limiting glucocorticoid use, or shows limited retinal detachment improvement after one week of high-dose systemic glucocorticoid
You will not qualify if you...
- Confirmed or suspected infectious uveitis caused by infections such as TB, CMV, HTLV-1, Whipple's disease, HZV, Lyme disease, toxoplasmosis, or HSV
- Corneal or lens opacity preventing fundus examination or likely requiring cataract surgery during the trial
- Previous use of anti-TNF or biologic therapies impacting non-infectious uveitis
- Received Ozurdex4 (dexamethasone implant) within 6 months before baseline
- Received intravitreal anti-VEGF therapy within 45 days for Lucentis4 or Avastin4, or within 60 days for anti-VEGF Trap before baseline
- Received intravitreal methotrexate within 90 days prior to baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on inflammation and treatment response
Participants receive adalimumab therapy or traditional therapy with glucocorticoids alone or combined with immunosuppressants for acute Vogt-Koyanagi-Harada disease.
Visits every two weeks for adalimumab injections; frequency may vary for traditional therapy group
Duration - Up to 1 year
Participants are followed for up to one year to monitor efficacy and side effects after treatment.
Periodic visits depending on treatment group and clinical status
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
X
xiaomin zhang, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here