Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis (NCT03066869) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
United States40 participantsStarted 2017-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of responders to Acthar at the end of treatment.