Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion: Twelve-month study results

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

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Design: Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. Participants: We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. Methods: At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 μm. Main Outcome Measures: The primary outcome for the open-label extension was safety; BCVA was also evaluated. Results: At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a

Original languageEnglish
Pages (from-to)2453-2460
Number of pages8
JournalOphthalmology
Volume118
Issue number12
DOIs
Publication statusPublished - Dec 2011

ASJC Scopus subject areas

  • Ophthalmology

Fingerprint Dive into the research topics of 'Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion: Twelve-month study results'. Together they form a unique fingerprint.

Cite this