Clinical Trial: Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids C

Brief 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.

Detailed 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.

H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol. Additionally H.P. Acthar gel is also reported to bind to melanocortin receptors. Melanocortin receptor activation has been shown to exert marked anti-inflammatory and immune-modulatory effects in animal studies, by modulating pro inflammatory cytokines, followed by induction of anti- inflammatory mediators and subsequent leukocyte migration. Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells. For this reason H.P. Acthar is an approved treatment for ocular inflammatory disease.

Ocular inflammatory disease 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.

Subjects will be treated with H P Acthar subcutaneous gel, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses with the same cumulative units to be administered, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

This will be a prospective open-label, non-randomized pilot study
Sponsor: Tampa Bay Uveitis Center, LLC

Current Primary Outcome:

  • Resolution of Inflammation: Anterior Uveitis [ Time Frame: 12 weeks ]
    2 step decrease in inflammatory score or down to grade 0 (Standardization of Uveitis Nomenclature, standardized and published for reporting clinical trials in uveitis:SUN criteria): Using the SUN criteria, inflammation can be graded on a scale from 0-4: subjects will be graded at baseline; resolution will graded as achieving the primary endpoint when the score decreases by 2 steps on the scale, or goes down to grade 0
  • Resolution of Inflammation: Retinal Vasculitis [ Time Frame: 12 weeks ]
    Clinical improvement of vasculitis, corroborated by angiographic evaluation: subjects with retinal vasculitis will have a retinal angiogram called a fluorescein angiogram at baseline and week 12, this will document areas of retinal vascular inflammation: Resolution will be graded at 12 weeks based on retinal leakage resolution on the fluorescein angiogram
  • Resolution of Inflammation:Intermediate Uveitis: Photographic haze reduced to grade 0 or down 2 steps documented with fundus photography [ Time Frame: 12 Weeks ]
    Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4, utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
  • Resolution of Inflammation: Clinically Significant Uveitic Macular Edema: Clinical improvement of macular edema with optical coherence tomography (OCT), which measures retinal thickness; documentation of central foveal thickness < 300 microns [ Time Frame: 12 weeks&n

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Change in visual acuity [ Time Frame: 12 and 24 weeks ]

    The visual acuity of subjects will be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. The ETDRS scores will be converted to a logarithmic scale, LogMar units, which will be utilized to calculate mean and median change in visual acuity score from baseline to 12 and 24 weeks


    Original Secondary Outcome: Same as current

    Information By: Tampa Bay Uveitis Center, LLC

    Dates:
    Date Received: April 25, 2016
    Date Started: July 2016
    Date Completion:
    Last Updated: January 7, 2017
    Last Verified: January 2017