Take Home Message from TREX-DME
The TREX-DME Trial was mainly designed to compare a monthly treatment regimen with ranibizumab to a Treat-and-Extend (TREX) regimen.
We added another arm to the protocol to study the effects of combining the treat and extend regimen with guided laser.
What the study shows is that, on average, Anti-VEGF treatment with ranibizumab in the TREX regimen allows the extension of treatment intervals, and can reduce injection burden.
Interestingly, the group of patients that received adjuvant laser showed a trend towards even fewer injections, with longer intervals.
We expect we may see a larger effect of the laser treatments when analyzing subgroups. In particular we will have a look at the results based on the type of edema –if it is pre-dominantly diffuse or focal.
Clinically it appears that circinate rings with active microaneuryms can be controlled with navigated laser. In patients with this type of angiographic appearance, I would expect better response from the navigated laser treatments than those with diffuse ooze unassociated with microaneuryms.
In another analysis we will evaluate the effect of laser in patients which respond quickly to Anti-VGEF and qualify for extension immediately vs. those who require constant Anti-VEGF injections.
Laser tends to show a positive long-term effect and trend, and there is still a year to go in this study.
The Navilas technology allows pre-planning of laser directly on fluorescein angiogram and oct macular maps. Then you can precisely track the laser plan and delivery of these targeted laser spots and patterns. All this with comprehensive digital documentation capabilities which provide the optimal foundation to analyze the results.
The Navilas laser also helped maintain consistency between the three study sites which is important.
So this laser is the best for my daily practice and the best choice for this study.
Our results show that Navilas did not compromise visual acuity. This is absolutely true. We did a lot of laser – on average 3 in year one and 2 in year two and the vision in the navigated laser arm was actually better than the monthly ranibizumab arm.
Basically, we will really learn that after finalizing the three year data and the subgroup analysis. However, I think whenever leaking microaneurisms are consistently present after a four injections loading phase, you should consider apply navigated laser.
Dr. Brown, we thank you for your time.
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- The treatment strategy and selected parameters presented in content listed here are solely the responsibility of the treating ophthalmologist, who is required to be familiar with the most recent literature/guidelines or recommendations, as well as with the usage of the Navilas Laser System according to the current Operator’s Manual.