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

June 29, 2018 updated by: Tampa Bay Uveitis Center, LLC

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Saint Petersburg, Florida, United States, 33709
        • Tampa Bay Uveitis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Subcutaneous injection twice weekly
Other Names:
  • Acthar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

December 20, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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