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

• ClinicalTrials.gov Identifier: NCT02764697
• Recruitment Status: Completed
• First Posted: May 6, 2016
• Results First Posted: July 2, 2018
• Last Update Posted: July 2, 2018
• Sponsor: Tampa Bay Uveitis Center, LLC
• Collaborator: Mallinckrodt
• Information provided by (Responsible Party): Tampa Bay Uveitis Center, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Uveitis; Anterior Uveitis; Intermediate Uveitis; Posterior Uveitis; Scleritis; Clinically Significant Macular Edema	Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION	Phase 4

Detailed Description:

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: 12 week treatment for active non-infectious uveitis, endpoint assessment and safety assessment; additional 12 week assessment for uveitis activity/quiescence and safety assessment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Cause Intolerable Side-Effects
• Actual Study Start Date: June 30, 2016
• Actual Primary Completion Date: December 7, 2016
• Actual Study Completion Date: December 20, 2016

Arms and Interventions

Arm	Intervention/treatment
H.P. Acthar Subcutaneous Gel Injection; For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.	Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION; Subcutaneous injection twice weekly; Other Name: Acthar

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With 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 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
2. Number of Participants With Clinically Significant Improvement of Macular Edema [ Time Frame: 12 weeks ]
   Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Tampa Bay Uveitis Center

Saint Petersburg, Florida, United States, 33709

Sponsors and Collaborators

Tampa Bay Uveitis Center, LLC

Mallinckrodt

Investigators

• Principal Investigator: Grace L Clarke; Tampa Bay Uveitis Center, LLC

More Information

• Responsible Party: Tampa Bay Uveitis Center, LLC
• ClinicalTrials.gov Identifier: NCT02764697
• Other Study ID Numbers: TBUC 10012015
• First Posted: May 6, 2016
• Results First Posted: July 2, 2018
• Last Update Posted: July 2, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Tampa Bay Uveitis Center, LLC:

Glaucoma associated with uveitis

Additional relevant MeSH terms:

Macular Edema; Uveitis; Uveitis, Anterior; Iridocyclitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Scleritis; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Uveal Diseases; Panuveitis; Iris Diseases; Choroiditis; Choroid Diseases; Scleral Diseases; Adrenocorticotropic Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs