Efficacy and Safety of H.P. ACTHAR GEL in Adults With Ret... | NCT03066869

NCT03066869

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
H.P. ACTHAR GEL	Experimental		Drug: H.P. ACTHAR GEL

Name	Type	Description	Arm Group Labels	Other Names
H.P. ACTHAR GEL	Drug	H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.	H.P. ACTHAR GEL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of responders to Acthar at the end of treatment.	A responder will be defined by the binominal presence or absence of active retinal vasculitis as evaluated at Week 24. Active retinal vasculitis is defined as angiographic leakage from retinal arterioles, venules, or capillaries as determined by investigator, seen on wide-field angiography. Complete resolution or absence of active retinal vasculitis at Week 24 is considered success or "remission".	24 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Presence or absence of active retinal vasculitis at all other time points.		1 Day to 24 Weeks
Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.		1 Day to 24 Weeks

Eligibility Module

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

ID	Term
D015866	Uveitis, Posterior
D031300	Retinal Vasculitis

ID	Term
D015864	Panuveitis
D014605	Uveitis
D014603	Uveal Diseases
D005128	Eye Diseases
D012164