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Multicenter Study Announced to Evaluate Novel Combination Therapy for Treatment of Diabetic Macular Edema

TREX-DME Trial to Validate Efficacy and Stability of Treatment with Navilas® Navigated Laser plus Ranibizumab

Teltow, Germany – OD-OS, the world leader in navigated laser therapy for retinal disease management, announced today that the Navilas® Laser has been selected for a new study to evaluate the efficacy and stability of laser plus anti-VEGF for the treatment of patients with diabetic macular edema. The investigator sponsored trial, conducted by David Boyer, MD (Retina-Vitreous Associates Medical Group, Beverly Hills, CA), David Brown, MD (Retina Consultants of Houston, TX), Lloyd Clark, MD and John Payne, MD (Palmetto Retina Center, West Columbia, SC), will compare the ranibizumab TReat and EXtend regimen with and without navigated retinal photocoagulation.  

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 diabetic macular edema.  
According to Dr. Boyer, “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.  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. John Payne, lead investigator, will coordinate the randomized multicenter trial for which enrollment has already begun.  The study will compare 60 patients treated with TREX plus adjunctive navigated laser treatment to 60 patients under the TREX regimen and 30 patients with monthly ranibizumab injections.  All patients will be followed for twenty-four months and evaluated for change in vision as well as number of injections.

“With anti-VEGF monotherapy for DME, we find most of these patients require ongoing treatment for a very long time,” stated Dr. David Brown.  “Therefore, we are anxious to see if we can improve treat and extend therapy with a navigated laser while reducing burden.  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.”

An earlier study by Marcus Kernt, MD (Ludwig Maximilians University, Munich) was presented at EURETINA 2013 in Hamburg.  Dr. Kernt’s study demonstrated that the combination of Navilas Navigated Laser plus ranibizumab injections on an as needed basis (PRN) reduced anti-VEGF retreatment rates by more than 50% while stabilizing visual gains.  At 12 months, 65% of the combination group required no further injections, while in the same period 84% of the ranibizumab monotherapy patients required additional injections to maintain effect.

When asked about the importance of this trial, Dr. Clark stated “We are eager to get started with this exciting protocol, evaluating a novel dosing strategy for anti-VEGF therapy in combination with a navigated laser.  The navigated laser enables us to standardize treatments which is essential for performing clinical trials.  Stabilizing visual gain is of paramount importance in managing these patients and we hope to demonstrate that this can be accomplished while reducing the number and frequency of injections.”   

OD-OS GmbH is located in Teltow, Germany where it has commercialized the Navilas Navigated Laser in the US, Canada, Europe, Korea and India.  Additional approvals are anticipated very soon in Japan, China and Mexico .  

For further information, please contact:
Dr. Erik Blazek

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