Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion

Julia A. Haller, Francesco Bandello, Rubens Belfort, Mark S. Blumenkranz, Mark Gillies, Jeffrey Heier, Anat Loewenstein, Young Hee Yoon, Marie Louise Jacques, Jenny Jiao, Xiao Yan Li, Scott M. Whitcup

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Abstract

Objective: To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Design: Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO). Participants: A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO. Intervention: A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426). Main Outcome Measures: The primary outcome measure for the pooled data from the 2 studies was time to achieve a ≥15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety. Results: After a single administration, the time to achieve a ≥15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P

Original languageEnglish
JournalOphthalmology
Volume117
Issue number6
DOIs
Publication statusPublished - Jun 2010

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ASJC Scopus subject areas

  • Ophthalmology

Cite this

Haller, J. A., Bandello, F., Belfort, R., Blumenkranz, M. S., Gillies, M., Heier, J., Loewenstein, A., Yoon, Y. H., Jacques, M. L., Jiao, J., Li, X. Y., & Whitcup, S. M. (2010). Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion. Ophthalmology, 117(6). https://doi.org/10.1016/j.ophtha.2010.03.032