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

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ClinicalTrials.gov Identifier: NCT03066869
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ocular Immunology and Uveitis Foundation

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.

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Vasculitis Retinal Drug: H.P. ACTHAR GEL Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Arm Intervention/treatment
Experimental: H.P. ACTHAR GEL Drug: H.P. ACTHAR GEL
H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.




Primary Outcome Measures :
  1. Percentage of responders to Acthar at the end of treatment. [ Time Frame: 24 Weeks ]
    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".


Secondary Outcome Measures :
  1. Presence or absence of active retinal vasculitis at all other time points. [ Time Frame: 1 Day to 24 Weeks ]
  2. Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications. [ Time Frame: 1 Day to 24 Weeks ]
  3. Percentage of patients requiring rescue therapy. [ Time Frame: 1 Day to 24 Weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066869


Locations
United States, Massachusetts
Ocular Immunology & Uveitis Foundation
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Ocular Immunology and Uveitis Foundation

Responsible Party: Ocular Immunology and Uveitis Foundation
ClinicalTrials.gov Identifier: NCT03066869     History of Changes
Other Study ID Numbers: 120160924
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uveitis
Vasculitis
Uveitis, Posterior
Retinal Vasculitis
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Panuveitis
Retinal Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs