April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
The SAKURA Study, a Phase III, Multicenter, Randomized, Double-Masked, Study of Intravitreal Injections of DE-109 for the Treatment of Active, Noninfectious Uveitis of the Posterior Segment: Baseline Ocular Disease Characteristics
Author Affiliations & Notes
  • Pauline Merrill
    Ophthalmology, Rush University, Chicago, IL
  • Quan Dong Nguyen
    Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaho, NE
  • W Lloyd Clark
    Palmetto Retina Center, West Columbia, SC
  • Laura Wilson
    Santen, Inc., Emeryville, CA
  • Marye Ellen Valentine
    Santen, Inc., Emeryville, CA
  • Joel Naor
    Santen, Inc., Emeryville, CA
  • Naveed Shams
    Santen, Inc., Emeryville, CA
  • Afsheen Khwaja
    Santen, Inc., Emeryville, CA
  • Yang Yang
    Santen, Inc., Emeryville, CA
  • Footnotes
    Commercial Relationships Pauline Merrill, Abbvie (C), Abbvie (F), Santen (C), Santen (F); Quan Dong Nguyen, Bausch & Lomb (C), Clearside (F), Genentech (F), Sanofi (C), Sanofi (F), Santen (C), Santen (F), XOMA (C), XOMA (F); W Clark, Genentech (C), Genentech (F), Pfizer (F), Regeneron (C), Regeneron (F), Santen (C), Santen (F); Laura Wilson, Santen (E); Marye Ellen Valentine, Santen (E); Joel Naor, Santen (E); Naveed Shams, Santen (E); Afsheen Khwaja, Santen (E); Yang Yang, Santen (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 109. doi:
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      Pauline Merrill, Quan Dong Nguyen, W Lloyd Clark, Laura Wilson, Marye Ellen Valentine, Joel Naor, Naveed Shams, Afsheen Khwaja, Yang Yang, ; The SAKURA Study, a Phase III, Multicenter, Randomized, Double-Masked, Study of Intravitreal Injections of DE-109 for the Treatment of Active, Noninfectious Uveitis of the Posterior Segment: Baseline Ocular Disease Characteristics. Invest. Ophthalmol. Vis. Sci. 2014;55(13):109.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: Uveitis is a multifactorial inflammatory condition that can affect any of the internal structures of the eye. Local treatment is currently limited predominantly to corticosteroids, which often have treatment-limiting adverse effects. Sirolimus (rapamycin) is a macrolide antibiotic with immunosuppressive, antifungal, antiangiogenic, and anti-inflammatory properties. Santen has developed a proprietary formulation of sirolimus (DE-109) for intravitreal administration in noninfectious uveitis of the posterior segment. The SAKURA development program is an international, multicenter, randomized, double-masked Phase 3 protocol assessing the safety and efficacy of 3 doses of DE-109 (44 µg, 440 µg, and 880 µg) administered by intravitreal injection every 2 months. This presentation examines the baseline ocular disease characteristics of subjects enrolled in the SAKURA study.

Methods: Subjects with active, noninfectious posterior, intermediate or panuveitis were enrolled and randomized for treatment at 103 sites from 15 countries as of March 31, 2013. Baseline anatomical characteristics for 347 subjects (347 eyes) are summarized.

Results: The subjects had been diagnosed with uveitis for a mean duration of 44.5 months (range, 0 to 412 months). The investigators characterized the uveitis as posterior (32.3%), intermediate (34.0%), intermediate and posterior (3.5%), or panuveitis (30.3%). The etiology of the uveitis was described as idiopathic (77.8%), Vogt-Koyanagi-Harada syndrome (5.2%), sarcoidosis (8.4%), birdshot (2.6%), serpiginous chorioretinopathy (0.3%), multifocal choroiditis (0.9%), HLA B27+ (1.4%), other autoimmune (2.3%), or not reported (0.9%). Most subjects had signs of moderate inflammation, with vitreous haze scores at baseline of 1.5+ (36.9%), 2+ (51.9%), 3+ (10.4%), or 4+ (0.9%). The baseline mean best-corrected visual acuity was 65.3 ETDRS letters [20/50] (range, 3 to 95 letters).

Conclusions: The ocular disease characteristics of the subjects enrolled in the SAKURA study are consistent with previously described populations of noninfectious uveitis of the posterior segment. The outcomes of the SAKURA study are expected to be generalizable for patients with different etiologies of uveitis as being evaluated in the clinical trial.

Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 557 inflammation • 746 uveitis-clinical/animal model  
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