April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
12-Month Evaluation of Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Central Retinal Vein Occlusion
Author Affiliations & Notes
  • F. Bandello
    Ophthalmology, University Vita Salute, Milan, Italy
  • M. S. Blumenkranz
    Ophthalmology-Sch of Med, Stanford University, Stanford, California
  • J. Jiao
    Allergan Inc., Irvine, California
  • X.-Y. Li
    Clinical Ophthalmology,
    Allergan, Inc., Irvine, California
  • S. M. Whitcup
    R & D,
    Allergan, Inc., Irvine, California
  • Footnotes
    Commercial Relationships  F. Bandello, Allergan, C; Novartis, C; Allergan, R; Novartis, R; M.S. Blumenkranz, Optimedica, I; Allergan, Macusight, Genentech, C; J. Jiao, Allergan, E; X.-Y. Li, Allergan, E; S.M. Whitcup, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 6397. doi:
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    • Get Citation

      F. Bandello, M. S. Blumenkranz, J. Jiao, X.-Y. Li, S. M. Whitcup; 12-Month Evaluation of Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6397.

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

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Purpose: : To evaluate the effects of dexamethasone intravitreal implant (DEX Implant; OZURDEXTM, Allergan, Inc) in patients with macular edema (ME) due to central retinal vein occlusion (CRVO).

Methods: : In 2 identical masked trials, patients with ME due to CRVO were randomized to receive DEX Implant 700µg, DEX Implant 350µg, or sham. Patients could receive open-label treatment with DEX Implant 700µg at day 180 if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250µm. Patients entering the open-label phase (treated or untreated) were followed for an additional 6 months. Key outcomes were BCVA, central retinal thickness, and safety.

Results: : At baseline, 136 patients received DEX Implant 700µg and 147 received sham; at Day 180, 114 patients from the 700µg group and 117 from the sham group received open-label treatment with DEX Implant 700µg. At least 15 letters of BCVA was gained in 31% of patients 60 days after the first DEX Implant 700µg (peak effect) and 27% gained ≥15 letters 60 Days after the second implant (Day 240); 21% of patients from the sham group who received their first DEX Implant 700µg at day 180 gained ≥15-letters by Day 240. Among patients who received a single, baseline DEX Implant 700µg (n=19), 53% of patients completed the study, 21% gained ≥15-letters at day 60, 42% at day 180, and 26% at day 360. Increases in IOP were generally transient and similar following each DEX treatment.

Conclusions: : In patients with ME due to CRVO, DEX Implant 700µg produced substantial improvements in BCVA and was well-tolerated. The response to a second DEX Implant after 6 months was similar.

Clinical Trial: : www.clinicaltrials.gov NCT00168324

Keywords: macula/fovea • corticosteroids 

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