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

NCT ID: NCT03066869

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2020-08-31

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.

Conditions

Uveitis, Posterior; Vasculitis Retinal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H.P. ACTHAR GEL

Group Type: EXPERIMENTAL

H.P. ACTHAR GEL

Intervention Type: DRUG

H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.

Interventions

H.P. ACTHAR GEL

H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Immunology and Uveitis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ocular Immunology & Uveitis Foundation

Waltham, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

C. Stephen Foster, MD

Role: CONTACT

sfoster@mersi.com

781-891-6377

Facility Contacts

C. Stephen Foster, MD

Role: primary

sfoster@mersi.com

781-891-6377

Stephen D. Anesi, MD

Role: backup

sanesi@mersi.com

781-891-6377

Other Identifiers

120160924

Identifier Type: -

Identifier Source: org_study_id