Phase
Condition
Uveitis
Posterior Uveitis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofthe following parameters in at least one eye despite at least 2 weeks of maintenancetherapy with oral prednisone (or oral corticosteroid equivalent):
- Has active, inflammatory, chorioretinal and/or inflammatory retinal vascularlesion
- 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 tothe minimum effective dose during the study.
- If under treatment with any immunosuppressants, immunomodulators, or biologic agentsfor a comorbid condition, has been on a stable dose for 2 weeks before screening
Exclusion
Exclusion criteria:
- Has proliferative or severe nonproliferative diabetic retinopathy, clinicallysignificant macular edema due to diabetic retinopathy, neovascular/wet age-relatedmacular degeneration, abnormality of vitreoretinal interface with the potential formacular structural damage independent of the inflammatory process or severe vitreoushaze that precludes visualization of the fundus at the Baseline Visit
- Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, pepticulcer, active infection, or any contraindication for treatment with Acthar Gel
Study Design
Connect with a study center
Retinal Research Institute, LLC
Phoenix, Arizona 85014
United StatesSite Not Available
Retina Center PC
Tucson, Arizona 85704
United StatesSite Not Available
Blue Ocean Clinical Research
Clearwater, Florida 33761
United StatesSite Not Available
University Retina and Macula Associates PC
Lemont, Illinois 60439
United StatesSite Not Available
Midwest Eye Institute
Indianapolis, Indiana 46290
United StatesSite Not Available
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts 02451
United StatesSite Not Available
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey 07650
United StatesSite Not Available
Metropolitan Eye Research and Surgery Institute
Teaneck, New Jersey 07666
United StatesSite Not Available
Bergstrom Eye Research, LLC
Fargo, North Dakota 58103
United StatesSite Not Available
Austin Retina Associates
Austin, Texas 78705
United StatesSite Not Available
Valley Retina Institute, PA
McAllen, Texas 78503
United StatesSite Not Available
Foresight Studies, LLC
San Antonio, Texas 78240
United StatesSite Not Available
Virginia Eye Consultants
Norfolk, Virginia 23502
United StatesSite Not Available

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