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27-04-2010 | Diabetes | Article

Ranibizumab plus laser treatment effective for diabetic macular edema

Abstract

Free abstract

MedWire News: Intravitreal ranibizumab plus prompt or deferred laser is more effective than a combination of triamcinolone and laser or laser alone for treating diabetic macular edema (DME), research shows.

“These results indicate a treatment breakthrough for saving the vision of people with diabetic macular edema,” said study author Neil Bressler (Johns Hopkins University School of Medicine, Baltimore, Maryland, USA).

“Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for patients with characteristics similar to those in this clinical trial.”

The researchers recruited 691 participants with Type 1 or Type 2 diabetes and DME involving the fovea to take part in the phase 3 study. This comprised a total of 854 eyes, as 24% of participants had treatment in both eyes. The participants had a visual acuity (approximate Snellen equivalent) ranging from 20/32 to 20/320 at baseline.

The team randomized each treated eye to sham injection plus prompt laser (n=293), ranibizumab 0.5 mg plus prompt laser (n=187), ranibizumab 0.5 mg plus deferred (for 24 weeks or more) laser (n=188), or triamcinolone 4 mg plus prompt laser (n=186) every 4 weeks for 12 weeks with additional treatment at the investigators discretion.

Best-corrected visual acuity achieved, and tolerability of treatment was assessed at 1 year. The two ranibizumab groups had the best improvement in visual acuity letter score from baseline at +9 for both the prompt and deferred laser groups, compared with +4 and +3 for the triamcinolone and sham injection groups, respectively. Two-year outcomes in visual acuity were similar to those achieved at 1 year.

Of note, the three active treatment groups had a similar reduction in mean central subfield thickness compared with the sham injection plus laser group.

The investigators observed no systemic events caused by the study treatment, but injection-related endophthalmitis developed in three eyes treated with ranibizumab .

“The results appear to be applicable to most people who have DME in the center of the macula with some vision loss, whether the person has Type 1 or Type 2 diabetes, is old or young, or is a woman or a man,” commented Bressler.

“Further follow-up is needed to determine even longer-term safety and efficacy of ranibizumab in the treatment of DME,” conclude the authors in the journal Ophthalmology.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

By Helen Albert