TY - JOUR
T1 - Ocular tolerability and efficacy of intravitreal and subconjunctival injections of sirolimus in patients with non-infectious uveitis
T2 - Primary 6-month results of the SAVE Study
AU - Nguyen, Quan Dong
AU - Ibrahim, Mohamed A.
AU - Watters, Anthony
AU - Bittencourt, Millena
AU - Yohannan, Jithin
AU - Sepah, Yasir J.
AU - Dunn, James P.
AU - Naor, Joel
AU - Shams, Naveed
AU - Shaikh, Ovais
AU - Leder, Henry Alexander
AU - Do, Diana V.
N1 - Funding Information:
The study drug was provided by Santen, Inc. The Johns Hopkins University has received research funding support from Santen, Inc. However, Santen, Inc. has had no role in the conduct of the index study.
PY - 2013
Y1 - 2013
N2 - Background: 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. 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. Results: At 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. Conclusion: Local 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.
AB - Background: 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. 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. Results: At 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. Conclusion: Local 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.
KW - Intravitreal
KW - Sirolimus
KW - Subconjunctival
KW - Uveitis
KW - mTOR
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U2 - 10.1186/1869-5760-3-32
DO - 10.1186/1869-5760-3-32
M3 - Article
C2 - 23514595
AN - SCOPUS:84883598411
SN - 1869-5760
VL - 3
SP - 1
EP - 15
JO - Journal of Ophthalmic Inflammation and Infection
JF - Journal of Ophthalmic Inflammation and Infection
IS - 1
M1 - 32
ER -