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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT03656692
Eligibility Criteria:
Inclusion criteria:
* Is male or nonpregnant, nonlactating female
* Has been diagnosed with current severe NIPPU
* Has active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):
1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
2. Has ≥ 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]
3. Has ≥ 1.5+ vitreous haze
* Is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study.
* If under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening
Exclusion criteria:
* Has proliferative or severe nonproliferative diabetic retinopathy, clinically significant macular edema due to diabetic retinopathy, neovascular/wet age-related macular degeneration, abnormality of vitreoretinal interface with the potential for macular structural damage independent of the inflammatory process or severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
* Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with Acthar Gel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03656692
Study Brief:
Protocol Section:
NCT03656692