Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

• Status: Terminated
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

Summary

The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

Also, safety information when using it for this purpose will be collected.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

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