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J. Naor, P. U. Dugel, D. A. Weber, DIAMOND Study Group; A Multicenter, Randomized, Double-Masked, Dose-Ranging, Placebo-Controlled Phase 2 Study to Assess Sirolimus in the Treatment of Patients With Diabetic Macular Edema (DIAMOND Study). Invest. Ophthalmol. Vis. Sci. 2010;51(13):4244.
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To evaluate the safety and efficacy of subconjunctival injections of the mTOR inhibitor, sirolimus in patients with diabetic macular edema.
Sirolimus, previously known as rapamycin, possesses potent immunomodulatory, anti-proliferative and anti-angiogenic properties. Through inhibition of the mammalian target of rapamycin (mTOR), sirolimus inhibits the expression of VEGF and down regulates hypoxia-inducible factor 1α. A proprietary depot-forming formulation (PerceivaTM, MacuSight, Inc., Union City, CA) has been developed for local sustained ocular administration. Phase I results in patients with DME and wet AMD demonstrated that Perceiva was well tolerated following either subconjunctival or intravitreal injection with minimal systemic exposure at all doses tested.In this dose-ranging, masked, placebo-controlled trial, patients were randomized 1:1:1:1 to 1 of 3 active arms of Perceiva (220, 440, or 880 µg) or placebo and received 2 subconjunctival injections, one at baseline and again at 3 months.Primary endpoints were evaluated at 6 months and included BCVA by ETDRS and retinal thickness.
A total of 131 patients were enrolled in 39 sites across the United States. All primary endpoint visits have been completed and data analysis is underway. Baseline characteristics for enrolled patients are presented in Table 1.
Comprehensive efficacy and safety results for the 6 months endpoint will be presented for the first time.
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