February 25, 2011
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Study supports ranibizumab, laser for patients with diabetic macular edema

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Neil M. Bressler, MD
Neil M. Bressler

KAANAPALI, Hawaii — Intravitreal ranibizumab with prompt or deferred focal/grid laser resulted in superior visual acuity and optical coherence tomography outcomes compared with focal/grid laser treatment alone in patients with visual impairment due to diabetic macular edema, a speaker said here.

Neil M. Bressler, MD, presented data at the Retina 2011 meeting from a recent Diabetic Retinopathy Clinical Research Network (DRCR.net) study supporting the use of anti-VEGF with prompt or deferred laser.

"We think that this should be considered now, recognizing the risk of endophthalmitis, in the management of diabetic macular edema, and it is very different from neovascular age-related macular degeneration," Dr. Bressler said.

The DRCR.net multicenter, randomized clinical trial included 854 eyes randomly assigned to receive either sham with prompt laser, Lucentis (ranibizumab, Genentech) with prompt laser, ranibizumab with deferred laser or triamcinolone with prompt laser.

Of the eyes treated with intravitreal ranibizumab and prompt or deferred focal/grid laser, approximately 50% had an improvement in visual acuity of 10 or more letters and approximately 30% gained 15 or more letters. Substantial visual acuity loss of 10 or more letters was uncommon, Dr. Bressler said.

Similar results were obtained when focal/grid laser was given starting with the first injection and when it was deferred by up to 6 months.

  • Disclosure: Dr. Bressler is principal investigator of grants sponsored by Genentech at Johns Hopkins University.

PERSPECTIVE

The Diabetic Retinopathy Clinical Research Network investigators reported that 1-year outcomes for ranibizumab combined with laser treatment were superior to 1-year outcomes for laser alone. With the recent publication of the READ-2 Study (Ranibizumab for Edema of the mAcula in Diabetes Phase 2 Study), the Resolve study and a press release from the Restore study, all looking at ranibizumab for treatment of diabetic macular edema, and the registration trials under way in the United States, it appears that FDA approval may come in the next year or two. Currently, ranibizumab therapy is still “off label,” but for me, it is reasonable and not experimental. The clinical practice paradigm shift to incorporate anti-VEGF therapy into the management of patients with diabetic macular edema is under way.

– Andrew P. Schachat, MD
Vice Chairman, Cole Eye Institute
Disclosure: Dr. Schachat has no direct financial interest in the products discussed in this article, nor is he a paid consultant for any companies mentioned.

Hawaiian Eye and Retina 2012 will be held January 15-20 at the Grand Wailea Resort & Spa in Maui. Learn more at OSNHawaiianEye.com or RetinaMeeting.com.