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

Last updated: July 12, 2021
Sponsor: Mallinckrodt
Overall Status: Terminated

Phase

4

Condition

Uveitis

Posterior Uveitis

Treatment

N/A

Clinical Study ID

NCT03656692
MNK61074105
  • Ages > 18
  • All Genders

Study 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.

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):
  1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascularlesion
  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 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

Total Participants: 5
Study Start date:
October 05, 2018
Estimated Completion Date:
July 14, 2020

Connect with a study center

  • Retinal Research Institute, LLC

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Retina Center PC

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Blue Ocean Clinical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • University Retina and Macula Associates PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Midwest Eye Institute

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Massachusetts Eye Research and Surgery Institution (MERSI)

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Metropolitan Eye Research and Surgery Institute

    Palisades Park, New Jersey 07650
    United States

    Site Not Available

  • Metropolitan Eye Research and Surgery Institute

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Bergstrom Eye Research, LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Valley Retina Institute, PA

    McAllen, Texas 78503
    United States

    Site Not Available

  • Foresight Studies, LLC

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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