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

NCT02764697 | Completed Phase 4 Results

• 1 other identifier: TBUC 10012015
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis; Anterior Uveitis; Intermediate Uveitis; Posterior Uveitis; Scleritis; Clinically Significant Macular Edema

Keywords

Glaucoma associated with uveitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography

  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

  Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness \< 300 microns

  12 weeks

Study Arms (1)

H.P. Acthar Subcutaneous Gel Injection

OTHER

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

Interventions

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION DRUG

Subcutaneous injection twice weekly

Also known as: Acthar

H.P. Acthar Subcutaneous Gel Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampa Bay Uveitis Center, LLC: lead
• Mallinckrodt: collaborator

Study Sites (1)

Tampa Bay Uveitis Center

St. Petersburg, Florida, 33709, United States

Location

MeSH Terms

Conditions

Uveitis; Uveitis, Anterior; Uveitis, Intermediate; Uveitis, Posterior; Scleritis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Panuveitis; Scleral Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Dr. Grace Levy Clarke
• Organization: Tampa Bay Uveitis Center, LLC

grace@tampabayuveitis.com

855 798 8393

Study Officials

• Grace L Clarke

  Tampa Bay Uveitis Center, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 6, 2016
• Study Start: June 30, 2016
• Primary Completion: December 7, 2016
• Study Completion: December 20, 2016
• Last Updated: July 2, 2018
• Results First Posted: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)