This study will evaluate the Efficacy and Safety of Infliximab versus Cyclophosphamide in
Subjects with Idiopathic Refractory Scleritis.
The term scleritis describes a chronic inflammation that involves the outermost cost and
skeleton of the eye. Scleritis is classified anatomically as either anterior or posterior
based on the principal location of the inflammation. Thirty to forty percent of scleritis
cases are associated with systemic autoimmune conditions including rheumatoid arthritis and
granulomatosis with polyangiitis. Infectious causes including herpes virus and varicella
zoster account for 5 to 10% of patients. The remaining 50% of cases are classified as
CIRIS, is the first prospective randomized, head to head study, comparing infliximab to
cyclophosphamide in refractory idiopathic scleritis. There is no firm evidence or randomized
controlled trials directly addressing the best biologic agent in severe and refractory
idiopathic scleritis. If left untreated or insufficiently treated, scleritis can progress to
peripheral ulcerative keratitis, uveitis and glaucoma. Visual loss occurs in approximately
10% of patients with anterior scleritis and in up to 75% of patients with posterior
scleritis. The incidence of burden in ocular inflammation (uveitis and scleritis) has been
dramatically reduced in the recent years with the use of biologics, raising the question of
whether these compounds should be used earlier in the treatment of severe non infectious
scleritis. Contrasting with other immunosuppressors, cyclophosphamide and infliximab act
rapidly and are highly effective in steroid's sparing.
Despite a strong rationale, these compounds are not yet approved in idiopathic refractory
scleritis, which guarantees the innovative nature of this study that aims selecting or
dropping any arm when evidence of efficacy already exists.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.