Abstract
BackgroundThe purpose of this study is to evaluate the ocular tolerability and efficacy of sirolimus administered as subconjunctival or intravitreal injections in patients with non-infectious uveitis. Sirolimus as a Therapeutic Approach for Uveitis (SAVE) is a prospective, randomized, open-label, interventional study. Thirty patients were enrolled and randomized in 1:1 ratio to receive either intravitreal injections of 352 μg sirolimus or subconjunctival injections of 1,320 μg at days 0, 60, and 120, with primary endpoint at month 6.ResultsAt month 6, all subjects with active uveitis at baseline showed reduction in vitreous haze of one or more steps. Forty percent of subjects showed reduction of two steps or more of vitreous haze (four in each group), and 60% showed a reduction of one-step vitreous haze (seven in group 1 and five in group 2). Changes in the inflammatory indices were statistically significant (p < 0.05) in both study groups. Thirty percent of patients gained one or more lines of visual acuity, 20% lost one or more lines, and 50% maintained the same visual acuity. There were no statistically significant differences between the two study groups at month 6. No serious adverse events were found to be related to the study drug.ConclusionLocal administration of sirolimus, either intravitreally or subconjunctivally, appears to be safe and tolerable. No drug-related systemic adverse events or serious adverse events were noted. Sirolimus delivered as either an intravitreal or subconjunctival injection has demonstrated bioactivity as an immunomodulatory and corticosteroid-sparing agent in reducing vitreous haze and cells, improving visual acuity, and in decreasing the need for systemic corticosteroids.
Highlights
The purpose of this study is to evaluate the ocular tolerability and efficacy of sirolimus administered as subconjunctival or intravitreal injections in patients with non-infectious uveitis
Since its first use in 1951, corticosteroids (CS) have been the first line of treatment for non-infectious uveitis and are the only class of drugs approved by the Food and Drug Administration (FDA) to treat such pathology [7]
Drugs that primarily target T-cells, like cyclosporine and tacrolimus, have demonstrated efficacy when employed in the treatment of uveitis [9,10,11,12,13]
Summary
The purpose of this study is to evaluate the ocular tolerability and efficacy of sirolimus administered as subconjunctival or intravitreal injections in patients with non-infectious uveitis. Since its first use in 1951, corticosteroids (CS) have been the first line of treatment for non-infectious uveitis and are the only class of drugs approved by the Food and Drug Administration (FDA) to treat such pathology [7]. Both systemic and the local forms of CS are used to treat posterior uveitis; not all patients, can tolerate their side effects. IMT has been employed to avoid further sequelae such as cataract, glaucoma, proliferative vitreoretinopathy, cystoid macular edema, vascular occlusion, and blindness [14]
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