Early immunosuppressive treatment for Vogt-Koyanagi-Harada disease
Official title: Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study
Run by University of Sao Paulo · NCT03399175 · Data updated 2026-11-12
This project tests whether starting high-dose corticosteroids plus immunosuppressive drugs at disease onset helps people with Vogt-Koyanagi-Harada disease control inflammation and protect vision.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | March 23, 2015 |
| Main results expected | May 18, 2023 |
| Study ends | December 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT03399175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with acute (onset) Vogt-Koyanagi-Harada disease who can start systemic high-dose corticosteroids and immunosuppressive medication and attend in-person follow-up in São Paulo for at least one year are the intended participants.
✕Probably not a fit
Patients with long-standing or chronic/recurrent VKH at presentation, or those unwilling/unable to adhere to systemic therapy or minimum follow-up, are unlikely to gain the intended benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, interventional program that enrolls patients at the onset of Vogt-Koyanagi-Harada disease and gives early systemic high-dose corticosteroids combined with immunosuppressive therapy. Patients are followed for at least 12 months with scheduled clinical exams and multimodal imaging including indocyanine green angiography and enhanced-depth imaging OCT, plus electroretinogram testing to detect subclinical choroidal inflammation. The protocol compares clinical and subclinical signs of activity over predefined intervals to characterize disease course under early combined therapy. Outcomes include inflammation control, visual function, and prevention of chronic complications such as choroidal neovascularization, cataract, and glaucoma.
Why it matters
Potential benefit: If successful, early combined therapy could reduce recurrent inflammation and preserve vision by preventing chronic complications.
How similar studies have gone: Previous reports suggest early aggressive immunosuppression can improve outcomes in VKH, but systematic use of ICGA, EDI-OCT and ERG to guide and document subclinical control remains less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: \- acute Vogt-Koyanagi-Harada disease Exclusion criteria: * non collaborative patient * minimum one-year follow-up
Where it's running
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Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Joyce H Yamamoto, MD — University of Sao Paulo School of Medicine Ophthalmology
- Study coordinator: Joyce H Yamamoto, MD
- Email: joycehy@uol.com.br
- Phone: 55-11-99266-6474
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.