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

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 <84 letters or retinal thickness 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 ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively.

CONCLUSIONS:

Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

• Authors: Julia A Haller, Francesco Bandello, Rubens Belfort Jr, Mark S Blumenkranz, Mark Gillies, Jeffrey Heier, Anat Loewenstein, Young Hee Yoon, Jenny Jiao, Xiao-Yan Li, Scott M Whitcup, Ozurdex GENEVA Study Group, Joanne Li
• Journal: Ophthalmology (Ophthalmology) Vol. 118 Issue 12 Pg. 2453-60 (Dec 2011) ISSN: 1549-4713 [Electronic] United States
• PMID: 21764136 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Drug Implants
• Glucocorticoids
• Dexamethasone

Topics

• Adult
• Aged
• Aged, 80 and over
• Cataract (chemically induced)
• Cataract Extraction
• Dexamethasone (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Implants
• Female
• Follow-Up Studies
• Glucocorticoids (administration & dosage, adverse effects)
• Humans
• Intraocular Pressure (drug effects)
• Macular Edema (drug therapy, physiopathology)
• Male
• Middle Aged
• Prospective Studies
• Retinal Vein Occlusion (drug therapy, physiopathology)
• Retreatment
• Treatment Outcome
• Visual Acuity (physiology)
• Vitreous Body