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

Stopped early · Phase 4

Conditions studied: Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

In brief

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.

Key facts

Study ID

NCT03656692

Run by

Mallinckrodt

People needed

5

Starts

2018-10-05

Expected to finish

2020-07-14

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
• Has ≥ 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
• 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

You may not qualify if…

• 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

Where it is running

• Blue Ocean Clinical Research — Clearwater, Florida, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Massachusetts Eye Research and Surgery Institution (MERSI) — Waltham, Massachusetts, United States
• Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States
• Bergstrom Eye Research, LLC — Fargo, North Dakota, United States
• Valley Retina Institute, PA — McAllen, Texas, United States
• Foresight Studies, LLC — San Antonio, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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