Trial | NCT03066869  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
Study Started
Mar 22
2017
Primary Completion
Feb 29
2020
Anticipated
Study Completion
Aug 31
2020
Anticipated
Last Update
Sep 12
2019

Drug H.P. ACTHAR GEL

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

H.P. ACTHAR GEL Experimental

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
No Results Posted