Recruiting

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

Sponsor:

Ocular Immunology and Uveitis Foundation

Code:

NCT03066869

Conditions

Uveitis, Posterior

Vasculitis Retinal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

H.P. ACTHAR GEL

Study Details

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 ID

NCT03066869

Start date

Mar 22, 2017

Status verified date

Sep, 2019

Completion date

Aug, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: H.P. ACTHAR GEL

Interventions

H.P. ACTHAR GEL

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

Primary outcome measure

Percentage of responders to Acthar at the end of treatment. [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

C. Stephen Foster, MD

781-891-6377 sfoster@mersi.com

Locations

Ocular Immunology & Uveitis Foundation

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

C. Stephen Foster, MD

781-891-6377 sfoster@mersi.com

Stephen D. Anesi, MD

781-891-6377 sanesi@mersi.com

Principal Investigator:

C. Stephen Foster, MD

More Information

Sponsor

Ocular Immunology and Uveitis Foundation

Last update posted

Sep 12, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ocular Immunology and Uveitis Foundation on 2019-09-12.