Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis

• ClinicalTrials.gov Identifier: NCT03066869
• Recruitment Status: Unknown
• First Posted: March 1, 2017
• Last Update Posted: September 12, 2019
• Sponsor: Ocular Immunology and Uveitis Foundation
• Information provided by (Responsible Party): Ocular Immunology and Uveitis Foundation

Study Description

Brief Summary:

The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.

Condition or disease	Intervention/treatment	Phase
Uveitis, Posterior; Vasculitis Retinal	Drug: H.P. ACTHAR GEL	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label, Single-center, Prospective Study on the Efficacy and Safety of Repository Corticotropin Injection (H.P. ACTHAR GEL) in the Treatment of Adults With Non-infectious Retinal Vasculitis
• Actual Study Start Date: March 22, 2017
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: August 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: H.P. ACTHAR GEL	Drug: H.P. ACTHAR GEL; H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.

Outcome Measures

Primary Outcome Measures :

1. Percentage of responders to Acthar at the end of treatment. [ Time Frame: 24 Weeks ]
   A responder will be defined by the binominal presence or absence of active retinal vasculitis as evaluated at Week 24. Active retinal vasculitis is defined as angiographic leakage from retinal arterioles, venules, or capillaries as determined by investigator, seen on wide-field angiography. Complete resolution or absence of active retinal vasculitis at Week 24 is considered success or "remission".

Secondary Outcome Measures :

1. Presence or absence of active retinal vasculitis at all other time points. [ Time Frame: 1 Day to 24 Weeks ]
2. Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications. [ Time Frame: 1 Day to 24 Weeks ]
3. Percentage of patients requiring rescue therapy. [ Time Frame: 1 Day to 24 Weeks ]

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:

• Any adult patient with active retinal vasculitis (involving arteries or veins) as a manifestation of non-infectious ocular inflammatory disease; fundus must be viewable with wide-field FA in the study eye
• If both eyes are involved, both are eligible for inclusion in the study
• Patients already on non-steroidal immunosuppressive therapy may continue on this during the study, but the dose must not be increased or decreased within 6 weeks of initiating the trial
• Willing and able to sign the informed consent form

Exclusion Criteria:

• Patients under age 18
• Patients who are pregnant (must be ruled out in women of child-bearing age)
• Active infectious ocular or systemic disease
• Patients with active infectious ocular or extraocular disease
• Patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously
• Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction
• Patients with known hypersensitivity to Acthar
• Patients on other non-steroidal systemic immunomodulatory medications with dose adjusted sooner than 6 weeks prior to study drug administration
• Patients currently on or recently treated with (within 6 weeks) systemic corticosteroid
• Patients with periocular or intraocular injections of medications administered to help control inflammation sooner than 6 weeks prior to study drug administration
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator, or contraindicated, including but not limited to, patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Administration of live or live attenuated vaccines is contraindicated in patients during the entire duration of the study and for one month prior

Contacts and Locations

Contacts

Contact: C. Stephen Foster, MD; 781-891-6377; sfoster@mersi.com

Locations

United States, Massachusetts

Ocular Immunology & Uveitis Foundation; Recruiting

Waltham, Massachusetts, United States, 02451

Contact: C. Stephen Foster, MD 781-891-6377 sfoster@mersi.com

Contact: Stephen D. Anesi, MD 781-891-6377 sanesi@mersi.com

Principal Investigator: C. Stephen Foster, MD

Sub-Investigator: Stephen D. Anesi, MD

Sub-Investigator: Peter Chang, MD

Sponsors and Collaborators

Ocular Immunology and Uveitis Foundation

More Information

• Responsible Party: Ocular Immunology and Uveitis Foundation
• ClinicalTrials.gov Identifier: NCT03066869
• Other Study ID Numbers: 120160924
• First Posted: March 1, 2017
• Last Update Posted: September 12, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uveitis; Uveitis, Posterior; Retinal Vasculitis; Vasculitis; Uveal Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Panuveitis; Retinal Diseases