Last updated on May 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Panuveitis | Posterior uveitis | Chronic cyclitis | Uveitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

  • Has been informed, understands the nature and risks of the study, and signed and dated the informed consent form
    • Has diagnosis of current severe NIPPU and 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 current or prior history of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):
      1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
      2. At least 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
      3. At least 1.5+ vitreous haze measurements (Nussenblatt et al, 1985)
    • If on concomitant immunosuppressive therapy at screening, has not had a dose increase in the 2 weeks prior to screening
    • If currently taking corticosteroids, is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study
    • If has solid tumor malignancy, but is not currently, and has not received therapy for it during the 3 years prior to Screening Visit might be eligible, after consulting with personal oncologist
    • If has treated and cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix might also be eligible
    • If has a comorbid condition and is being treated with immunosuppressants and/or immunomodulators, has been at a stable dose at least 2 weeks prior to screening
    • Is of nonchildbearing potential or is nonpregnant, nonlactating and agrees to use protocol-defined effective contraception throughout study participation until the Follow-up Visit
    • Has a mean systolic blood pressure 150 mm Hg and a diastolic blood pressure of 90 mm Hg determined by the average of 3 seated readings taken at least 5 minutes apart at the Screening and Baseline Visits

Exclusion Criteria:

  • Is from a vulnerable population (per 45CFR46 and/or other local and national regulations), including but not limited to:
    1. Employees (temporary, part-time, full time, etc)
    2. A family member of the research staff conducting the study, or of the sponsor, of the clinical research organization, or of the ethics committee (IRB/IEC)
  • Has history of sensitivity to ACTH preparations or sensitivity to porcine protein products
  • Has had (within the previous 6 months) diabetic retinopathy, age-related macular degeneration, intraocular surgery, ocular trauma, cataracts, or posterior capsule opacification
  • Had a glucocorticosteroid implant (such as Retisert, Iluvien, or Yutiq) within 3 years prior to the Baseline Visit, complications related to the device, had one removed within 90 days prior to the Baseline Visit, and/or had complications related to removal of the device
  • Received intraocular or periocular corticosteroids within 30 days prior to Baseline Visit
  • Has proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Has neovascular/wet age-related macular degeneration
  • Has an abnormality of a vitreoretinal interface (ie, vitreomacular traction, epiretinal membranes, etc) with the potential for macular structural damage independent of the inflammatory process
  • Has a severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
  • Has any known contraindication(s) to Acthar Gel including, but not limited to: known history of scleroderma, osteoporosis, or ocular herpes simplex. For the purposes of this trial, osteoporosis is defined as evidence of current vertebral or long bone fracture, or a bone density lumbar T-score > 2.0 standard deviations (SD) below the mean of the reference population
  • Has primary adrenocortical insufficiency, or adrenal cortical hyperfunction
  • Has current congestive heart failure (as defined by New York Heart Association)
  • Has history of chronic active hepatitis including active or chronic hepatitis B, or acute or chronic hepatitis C
  • Has history of tuberculosis (TB) infection, close contact with an individual with an active TB infection, or signs/symptoms of TB or a positive or indeterminate interferon gamma release assay (IGRA) for TB at screening
  • Has known immune compromised status (not related to disease/condition under study), including, but not limited to individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus
  • Has any of the protocol-defined laboratory abnormalities at the Screening Visit
  • Has other clinically significant disease, disorder or laboratory abnormality (even if included on the package insert) which the investigator thinks might put the patient at risk, make them unable to complete the study, or influence the study results

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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