Transcript
Announcer:
Welcome to CE on ReachMD. This activity, titled Best Practices for Optimized Photobiomodulation Treatment Effect: Candidate Selection is provided by Evolve Medical Education.
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Dr. Munk:
This is CE on ReachMD, and I'm Marion Munk. I'm joined by my colleague, Diana Do. Thanks for joining us today. We're going to discuss the patients best suited for multiwavelength photobiomodulation therapy as delivered in the LIGHTSITE-III trial. For that, let's have a look at the label. So what kind of patients are allowed to be treated according to label, Diana?
Dr. Do:
Thank you for letting me join you, Marion. It's really important to look at the patient population in the LIGHTSITE-III clinical trial. These patients had intermediate age-related macular degeneration with the presence of at least 3 medium-sized drusen. In particular, their visual acuity to enroll in the clinical trial was equivalent to a Snellen of 20/32 to 20/100.
In terms of inclusion criteria, another important question is the use of concomitant medications. And, in fact, in the LIGHTSITE III clinical trial, many patients who were stable were still on their AREDS vitamins throughout the study. Over 85% of patients were taking these multivitamins. And in addition, it’s important to consider that patients who have active wet age-related macular degeneration in the fellow eye were also allowed to be enrolled in the trial.These patients may have been receiving intravitreal anti-VEGF therapy in their fellow eye as well.
Marion, I wanted to ask you in the clinical trial, were patients with geographic atrophy allowed to receive photobiomodulation?
Dr. Munk:
Yes, very important question, and the answer is yes, but only patients with noncentral-involving geographic atrophy. So patients who had geographic atrophy within the central millimeter of the retina and of the macula were not allowed to be included, and this is also reflected in the label. So in the label, like you said, intermediate AMD patients and patients with noncentral geographic atrophy are allowed to be treated with the multiwavelength photobiomodulation.
What about neovascular AMD, Diana?
Dr. Do:
Neovascular AMD was also an exclusion criteria. So photobiomodulation as delivered in the LIGHTSITE-III clinical trial excluded eyes with neovascular AMD.
Dr. Munk:
That's very interesting, because actually what we see here, the label really directly reflects the patient population, which were included in the LIGHTSITE-III. Correct?
Dr. Do:
That is correct. And I think it's important, as physicians get used to utilizing photobiomodulation as delivered in the LIGHTSITE-III clinical trial, that we select the appropriate patients who might benefit from this new treatment.
Dr. Munk:
Totally agree with you. I think it's worth mentioning here that the US label here is really very strict. However, we in Europe, we have a much broader label. So actually, we are allowed to treat any patients with dry age-related macular degeneration, even patients with fluid due to macular edema, for example. And this reflects more the patient inclusion criteria from the LIGHTSITEI and II trial where actually all kinds of patients with dry age-related macular degeneration were allowed from visual acuity from 20/20 ranging up to 20/100, and patients with only very small drusen up to center-involving geographic atrophy.
Dr. Do:
Well, this has been very useful. It's always good to review which patients might be best suited to receiving this new device therapy. And thank you again for all this information.
Dr. Munk:
Thank you, Diana.
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