April 2010
Volume 51, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2010
Double-Masked, Sham-Controlled, Randomized Study of Dexamethasone Intravitreal Implant for the Treatment of Uveitis
Author Affiliations & Notes
  • S. M. Whitcup
    R & D,
    Allergan, Inc., Irvine, California
  • S. Lightman
    Clinical Ophthalmology, Moorfields Eye Hospital, London, United Kingdom
  • R. Belfort
    Opthalmology, Vision Institute, Sao Paulo, Brazil
  • C. Y. Lowder
    Cole Eye Inst-Ophthalmology, Cole Eye Institute, Cleveland, Ohio
  • C. Foster
    Ophthalmology, Ocular Immunology and Uveitis Foundation, Cambridge, Massachusetts
  • M. R. Robinson
    Ophthalmology,
    Allergan, Inc., Irvine, California
  • R. M. Schiffman
    R & D,
    Allergan, Inc., Irvine, California
  • X.-Y. Li
    Clinical Ophthalmology,
    Allergan, Inc., Irvine, California
  • H. Cui
    Allergan, Inc., Irvine, California
  • Footnotes
    Commercial Relationships  S.M. Whitcup, Allergan, E; S. Lightman, Allergan, C; R. Belfort, Alcon, I; Allergan, Alcon, C; C.Y. Lowder, Allergan, F; C. Foster, Alcon, Allergan, Bausch & Lomb, Inspire, Ista, LUX, Sirion, F; Abbott, Alcon, Allergan, Bausch & Lomb, Eyegate, Genentech, Inotech, Inspire, Ista, LUX, Merrimack, Novartis, Sirion, Therakine, C; Alcon, Allergan, Bausch & Lomb, Inspire, Ista, LUX, Sirion, R; M.R. Robinson, Allergan, E; R.M. Schiffman, Allergan, E; X.-Y. Li, Allergan, E; H. Cui, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 6381. doi:
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      S. M. Whitcup, S. Lightman, R. Belfort, C. Y. Lowder, C. Foster, M. R. Robinson, R. M. Schiffman, X.-Y. Li, H. Cui; Double-Masked, Sham-Controlled, Randomized Study of Dexamethasone Intravitreal Implant for the Treatment of Uveitis. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6381.

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

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Abstract

Purpose: : To evaluate the a dexamethasone intravitreal implant(OZURDEXTM) in patients with uveitis.

Methods: : In this 26-week trial, patients with noninfectious, intermediate, or posterior uveitis were randomized to receive DEX Implant 700µg (n=77), DEX Implant 350µg (n=76), or sham (n=76). The primary endpoint was the proportion of patients with vitreous haze score of 0 at Week 8. Other endpoints included best-corrected visual acuity (BCVA) and safety.

Results: : The proportion of patients with a vitreous haze score of 0 at week 8 was 46.8% with DEX Implant 700µg, 35.5% with DEX Implant 350µg, and 11.8% with sham (P<.001); this benefit persisted through week 26. A gain of ≥15 letters from baseline BCVA was seen in significantly more patients in the DEX Implant groups than the sham group at all study visits; at week 8, 42.9% in the DEX Implant 700µg group, 39.5% in DEX Implant 350µg group, and 6.6% in sham group (P<.001). Overall, the 700µg dose was more effective than 350µg dose. The percentage of patients with IOP ≥25 mmHg peaked at 7.1% for DEX Implant 700µg, 8.7% for DEX Implant 350µg, and 4.2% for sham (no statistically significant between-group difference at any visit). Cataracts were reported as adverse events in 11/76 DEX Implant 700µg patients, 10/74 DEX Implant 350µg patients, and 8/75 sham patients (P=.769).

Conclusions: : In patients with non-infectious intermediate or posterior uveitis, a single dose of DEX Implant was well-tolerated and produced significant improvements in intraocular inflammation and visual acuity persisting for 6 months. Overall, DEX Implant 700µg demonstrated greater efficacy than DEX Implant 350µg with similar safety.

Clinical Trial: : www.clinicaltrials.gov NCT00333814

Keywords: uveitis-clinical/animal model • corticosteroids • retina 
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