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

• Status: Completed
• Trial end date: 2016-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampa Bay Uveitis Center, LLC
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

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