A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
ATLAS study is a clinical trial to evaluate the potential role of subcutaneous
adrenocorticotropic hormone (ACTH) gel in the management of non-infectious scleritis.
Specifically, the ATLAS Study aims to evaluate the safety, tolerability and effect of 2
different dose regimens of ACTH gel administered by subcutaneous (SC) injection in patients
with scleritis, over a period of 12 months.
Scleritis is an inflammatory disease affecting the sclera (white outer coating of the eye),
which causes blurring of vision, redness, tearing and painful ocular inflammatory episodes in
one or both eyes. Scleritis may results in vision threatening ocular complications, if left
untreated. Treatment of scleritis is usually chronic and requires systemic therapy with
non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive therapy. Due to
its treatment resistance nature, scleritis remains a therapeutic challenge for many
ophthalmologists.
H.P. Acthar Gel (ACTH Gel) is a highly purified preparation of adrenocorticotropic hormone
(ACTH) in a gel that is designed to provide extended release of the ACTH following injection.
It is a FDA approved treatment for flares or on a regular basis (maintenance) in people with
systemic lupus erythematosus (lupus), infantile spasms, adults with acute relapses or flares
of multiple sclerosis (MS), patients with kidney diseases, among other indications. ACTH Gel
is also approved for a wide range of allergic and inflammatory diseases of the eye.
Given the established role of inflammation in the pathogenesis of scleritis and the
anti-inflammatory effects of ACTH Gel treatment by blocking various inflammatory pathways, a
beneficial outcome could be anticipated from ACTH Gel treatment in patients with scleritis.
Phase:
Phase 2
Details
Lead Sponsor:
Metropolitan Eye Research & Surgery Institute
Collaborators:
Colorado Retina Associates Foresight Studies, LLC Mallinckrodt Ocular Imaging Research and Reading Center Stanford University Texas Retina Associates University of Louisville Weill Medical College of Cornell University