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J. A. Haller, F. Bandello, J. Jiao, X.-Y. Li, S. M. Whitcup; 12-Month Evaluation of Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Branch Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2439. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the effects of OZURDEX (dexamethasone intravitreal implant) in patients with macular edema (ME) due to branch retinal vein occlusion (BRVO).
In 2 identical masked studies, eyes with ME due to BRVO were randomized to receive DEX Implant 0.7 mg, DEX Implant 0.35 mg, or sham. Patients could receive open-label treatment with DEX Implant 0.7 mg at Day 180 if best-corrected visual acuity (BCVA) was 250µm. Eyes 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, 291 eyes received DEX Implant 700µg and 279 received sham; of these 241/291 (83%) in the DEX Implant group and 235/279 (84%) in the Sham group had BRVO for >90 days. At Day 180, 227 from the 0.7 mg group and 210 from the sham group received open-label treatment with DEX Implant 0.7 mg. At least 15 letters of BCVA was gained in 30% of eyes 60 Days after the first DEX Implant 0.7 mg (peak effect) and 34% gained >/=15 letters 60 Days after the second implant (Day 240); 29% of eyes from the sham group that received their first DEX Implant 0.7 mg at Day 180 gained >/=15-letters by Day 240. Among eyes that only received a single, baseline DEX Implant 0.7 mg (n=61), 30% gained >/=15-letters at Day 60, 46% at Day 180, and 43% at Day 360. Eyes with BRVO <=90 days responded better than eyes with chronic ME. Increases in IOP were similar and generally transient following each DEX Implant.
In patients with ME due to BRVO, DEX Implant 0.7 mg produced substantial improvements in BCVA and was well-tolerated. The response to a second DEX Implant 0.7 mg after 6 months was similar.
Clinical Trial: :
www.clinicaltrials.gov NCT00168298, NCT00168324
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