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Nirali Bhatt, Monica D Dalal, William R Tucker, Robert B Nussenblatt, H Nida Sen; Subconjunctival Sirolimus in the Treatment of Autoimmune Non-Necrotizing Anterior Scleritis: Results of a Pilot Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5298.
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Scleritis is a chronic, painful and potentially blinding inflammatory disease. Sirolimus suppresses cytokine-driven T-cell proliferation, inhibiting the activity of many growth factors relevant to scleritis. This study investigates the safety, tolerability and efficacy of subconjunctival sirolimus injections as a treatment for active, autoimmune, non-necrotizing, anterior scleritis.
Five participants with active, autoimmune, non-necrotizing anterior scleritis with scleral inflammatory grade of ≥1+ in at least one quadrant with a history of flares were enrolled in this phase I/II, single-center, open-label, non-randomized, prospective pilot study. Patients received a baseline injection with the primary outcome measure of at least a 2-step reduction or reduction to grade zero scleral inflammation according to a standardized photographic grading scale in the study eye by eight weeks. Secondary outcomes included changes in visual acuity, ability to taper from their standard immunosuppressive regimen, number of partients who experienced a disease flare, and those requiring re-injection. Safety outcomes include the number and severity of systemic and ocular toxicities, adverse events, vision loss ≥ 15 ETDRS letters, and rise in intraocular pressure. The study included six visits over four months with an extension phase to one year.
All patients (N=5, 100%) achieved at least a 2-step reduction or reduction to grade zero inflammation in the study eye by the Week 8 visit. Mean baseline visual acuity was 84.6 ETDRS letters and 84.4 at the end of the study. None of the patients who were previously on systemic immunosuppressive medications (N=4) were successfully tapered off therapy during the study. Three out of five patients (60%) experienced disease flares requiring re-injection. No systemic toxicities were observed, and none of the patients experienced a rise in intraocular pressure. Two patients (40%) experienced a localized sterile inflammatory reaction at the site of the subconjunctival injection which resolved without complication. One of these patients withdrew from the study during the extension phase.
Subconjunctival sirolimus leads to a short-term reduction in scleral inflammation, though relapses requiring re-injection do occur. A local sterile conjunctival inflammatory reaction was an ocular side effect observed during this study.
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