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

Uveitis, Posterior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03066869
• Other study ID #: 120160924
• Status: Recruiting
• Phase: Phase 4
• Start date: March 22, 2017
• Est. completion date: August 2020

Study information

• Verified date: September 2019
• Source: Ocular Immunology and Uveitis Foundation
• Contact: C. Stephen Foster, MD
• Phone: 781-891-6377
• Email: sfoster[@]mersi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Vasculitis
• Uveitis
• Uveitis, Posterior
• Vasculitis
• Vasculitis Retinal

Intervention

Drug:
• H.P. ACTHAR GEL
H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.

Locations

Country	Name	City	State
United States	Ocular Immunology & Uveitis Foundation	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Immunology and Uveitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of responders to Acthar at the end of treatment.	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".	24 Weeks
Secondary	Presence or absence of active retinal vasculitis at all other time points.		1 Day to 24 Weeks
Secondary	Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.		1 Day to 24 Weeks
Secondary	Percentage of patients requiring rescue therapy.		1 Day to 24 Weeks