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OD-OS has announced that its Navilas laser has been selected for a new study to evaluate the efficacy and stability of laser plus anti-vascular endothelial growth factor for the treatment of patients with diabetic macular edema (DME).
Teltow, Germany-OD-OS has announced that its Navilas laser has been selected for a new study to evaluate the efficacy and stability of laser plus anti-vascular endothelial growth factor for the treatment of patients with diabetic macular edema (DME).
The investigator-sponsored trial will compare the ranibizumab treat and extend regimen with and without navigated retinal photocoagulation.
It was conducted by David Boyer, MD, Retina-Vitreous Associates Medical Group, Beverly Hills, CA; David Brown, MD, Retina Consultants of Houston; Lloyd Clark, MD; and John Payne, MD, Palmetto Retina Center, West Columbia, SC.
The goal of the study is to evaluate two treat and extend strategies, and to demonstrate a reduction of treatment burden without compromising visual outcome in patients with DME.
“If the laser does what we’re hoping it will do, it will improve our compliance tremendously because we’re going to reduce the number of injections,” Dr. Boyer said. “Patients don’t mind coming in every 2, 2 ½, or even 3 months, but when you have to come monthly for 1 or 2 years, they become disenchanted with continuing the treatment.”
Dr. Payne, the study’s lead investigator, will coordinate the randomly assigned multicenter trial for which enrollment has already begun. It will compare 60 patients treated with the regimen plus adjunctive navigated laser treatment to 60 patients under only the regimen, and 30 patients with monthly ranibizumab injections.
“We are anxious to see if we can improve treat and extend therapy with a navigated laser while reducing burden,” Dr. Brown said. “The precision of an image-guided laser enables us to perform more complete and accurate treatments that were simply not possible with conventional or pattern lasers.”
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