Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05015335
Eligibility Criteria:
Inclusion Criteria:
1. Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.
2. Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month
3. Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.
Exclusion Criteria:
1. Any contraindication to administration of immunosuppressive therapy (active tuberculosis, immune deficit, opportunistic infection, other severe chronic disease).
2. Previous diagnosis or signs of demyelinating disease of the central nervous system.
3. Children unable to cooperate with examinations and follow-up.
4. Positive allergy skin test when conducting fluorescence fundus angiography.
5. Diffuse vascular leakage, macula edema or any retina lesions demonstrated by UWFFA.
6. History of oral immunosuppressive drug treatment within 2 months
7. History of biological treatment within 2 months
8. History of triamcinolone acetonide subconjunctival/intraocular injection within 3 months
9. Current topical steroid use more than six times per day
10. History of eye surgery within 3 months.
11. Eye complications that interfere with fundus observation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT05015335
Study Brief:
Protocol Section:
NCT05015335