Elsevier

Ophthalmology

Volume 118, Issue 12, December 2011, Pages 2453-2460
Ophthalmology

Original article
Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion: Twelve-Month Study Results

Presented at: the 33rd Annual Macula Society Meeting, February 24–27, 2010, Tucson, Arizona.
https://doi.org/10.1016/j.ophtha.2011.05.014Get rights and content

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.

Section snippets

Study Design

Two identical, prospective, multicenter, phase III clinical trials were conducted. Each trial consisted of a 6-month, randomized, sham-controlled, parallel-group, double-masked phase followed by a 6-month open-label extension. Each of the trials enrolled both BRVO and CRVO patients. The protocol for the initial, 6-month, double-masked phase of the trials has been described in detail previously7 and is summarized later.

Both trials were conducted in compliance with the tenets of the Declaration

Results

Figure 1 illustrates the flow of patients through the 12-month study. A total of 1256 patients received a first injection with either DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) at the start of the study. At day 180, 1196 of the patients completed the initial double-masked phase of the study, and 997 of the study eyes received open-label DEX implant 0.7 mg. Of these 997 eyes, 99% met the visual acuity or retinal thickness criteria for retreatment, whereas 1%

Discussion

Reinjection with DEX implant 0.7 mg in patients who met retreatment criteria for macular edema owing to BRVO or CRVO in this study was safe and well-tolerated over 12 months. The safety profile after a second treatment with DEX implant 0.7 mg was generally similar to that seen after the first treatment, except that more cataract progression occurred in eyes that received retreatment with 0.7 mg DEX implant. Steroid-induced increases in IOP after each DEX implant treatment were predictable and

Acknowledgments

Amy Lindsay, PhD, and Kate Ivins, PhD, provided professional writing assistance (funded by Allergan, Inc.) with the preparation of the manuscript but did not meet authorship criteria.

References (8)

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  • A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study report 6

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  • P.A. Campochiaro et al.

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There are more references available in the full text version of this article.

Cited by (0)

Manuscript no. 2011-74.

Financial Disclosure(s): The authors have made the following disclosures:

Julia A. Haller - Consultant - Allergan, Genentech, Regeneron.

Francesco Bandello - Consultant - Allergan, Bayer, Novartis, Thea, Pfizer, Alcon.

Rubens Belfort Jr - Consultant - Alcon, Allergan.

Mark S. Blumenkranz - Consultant - Allergan, Genentech; Equity Owner - Optimedica.

Mark Gillies - Consultant - Allergan, Novartis, Pfizer; Lecture Fees - Allergan; Research Support - Allergan, Novartis.

Jeffrey Heier - Consultant, Research Support - Alimera, Allergan, Genentech, Regeneron.

Anat Loewenstein - Consultant - Allergan.

Young Hee Yoon - Consultant - Allergan, Bayer, Novartis; Lecture Fees - Alcon, Allergan, Bayer.

Jenny Jiao - Employee - Allergan.

Xiao-Yan Li - Employee - Allergan.

Scott M. Whitcup - Employee, Equity Owner - Allergan.

Sponsored by Allergan, Inc. The sponsor participated in the design of the study, conducting the study, data management, data analysis, interpretation of the data, and the preparation, review, and approval of the manuscript.

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The GENEVA (Global Evaluation of implaNtable dExamethasone in retinal Vein occlusion with macular edemA) Study Group Investigators are listed online at http://aaojournal.org. The GENEVA Study Group Writing Committee: Francesco Bandello, Rubens Belfort Jr, Mark Gillies, Julia A. Haller (Chair), Jeff Heier, Anat Loewenstein, Mark S. Blumenkranz, Young Hee Yoon, Joanne Li, and Scott M. Whitcup.

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