Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
Condition: Uveitis; Anterior Uveitis; Intermediate Uveitis; Posterior Uveitis; Scleritis; Clinically Significant Macular Edema
MeSH terms: Macular Edema; Uveitis; Uveitis, Anterior; Iridocyclitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Scleritis
Intervention: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Intervention description: Subcutaneous injection twice weekly
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma associated with uveitis

Summary:

      Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory
      reaction involving ocular tissue and vasculature. The inflammation usually causes pain,
      redness, photophobia and blurred vision. This inflammation, is typically treated with
      regional or systemic therapy. The regional therapy typically consists of topical
      corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a
      steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to
      evaluate the possible effectiveness of H.P. Acthar in patients with active ocular
      inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has the ability to understand and sign the informed consent document

          -  Subject is 18 years of age or older

          -  Subject can be male or female

          -  Subject has negative Purified Protein Derivative (Tuberculosis skin test) or
             quantiferon TB Gold Test (blood test for TB) testing done in 3 months

          -  Subject has active ocular inflammation in at least one eye

          -  Subject has visual acuity in at least one eye of 20/400 or better.

          -  Subject has a history of glaucoma or has actively treated glaucoma

          -  Subject is willing and able to comply with the study procedures

          -  Female subjects of childbearing potential must not be pregnant or breast-feeding, must
             have a negative pregnancy test at screening and must be willing to undergo pregnancy
             testing throughout the study

        Exclusion Criteria:

          -  Subject has any ocular infection

          -  Subject has any systemic infection

          -  Participant has documented immunocompromised or immune-incompetent state

          -  Subject has any ocular co-morbidity than prevents assessment of intraocular
             inflammation

          -  Subject has had any intra-ocular surgery in previous 6 weeks

          -  Subject has any planned elective surgery ocular or systemic during study duration

          -  Subject is pregnant or breast-feeding

          -  Subject had a recent vaccination with live or attenuated vaccines

          -  Subject has a sensitivity to Porcine derived proteins

          -  Subject has a medical history which is a contraindication to receiving H.P. Acthar