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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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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).
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.
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.
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.
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