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R. Belfort, Jr., J. S. Heier, J. A. Haller, M. S. Blumenkranz, F. Bandello, A. Loewenstein, Y. Yoon, J. Jiao, X.-Y. Li, S. M. Whitcup; Benefits of Early Treatment With Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to BRVO or CRVO Over 12 Months. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6398.
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To compare early and delayed treatment with OZURDEXTM (dexamethasone intravitreal implant) in patients with macular edema (ME) due to branch or central retinal vein occlusion (RVO).
In 2 identical studies, patients with ME due to RVO 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 250 µm. All patients entering the open-label phase were followed for another 6 months.
At baseline, 427 patients received DEX Implant 0.7 mg and 426 received sham. At Day 180, 341 from the 0.7 mg group and 327 from the sham group entered the open-label phase and were treated with DEX Implant 0.7 mg. The percentage of patients who gained >=15 letters of BCVA 60 days (peak response) after the first 0.7 mg implant was 30% among patients with their first implant at baseline and 26% among patients with first implant delayed until Day 180 (initially from sham group). Mean increase in BCVA 60 days after the first 0.7 mg implant was 10 letters among patients with their first implant at baseline and 7 letters among patients with their first implant at Day 180. The percentage of patients who lost ≥15 letters of BCVA 180 days after the first 0.7 mg implant was 6% among patients with their first implant at baseline and 11% among patients with their first implant at Day 180.
In patients with ME due to BRVO or CRVO, earlier treatment with DEX Implant 0.7 mg resulted in a greater response to treatment.
Clinical Trial: :
www.clinicaltrials.gov NCT00168298, NCT00168324
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