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



Status:Active, not recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:8/26/2018
Start Date:March 22, 2017
End Date:December 2018

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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

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.


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
We found this trial at
1
site
Waltham, Massachusetts 02451
Principal Investigator: C. Stephen Foster, MD
Phone: 781-891-6377
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mi
from
Waltham, MA
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