An overview of the PALADIN study for diabetic macular edema (DME)

Mathew MacCumber, MD, PhD, FASRS, spoke with Modern Retina about his presentation at the recent Retina Society meeting in New York City titled, "0.19 mg Fluocinolone Acetonide (FAc) Implant Improves Vision and Treatment Burden in Patients with Diabetic Macular Edema: The PALADIN Study."

Video Transcript

Editor's note - This transcript has been edited for clarity.

Sydney M. Crago: Hey, I'm Sydney Crago here with Modern Retina, and today we're discussing the results of the PALADIN study. Dr. MacCumber, could you share a little bit about the study results?

Mathew MacCumber, MD, PhD, FASRS: Yes, thank you. It's Dr. Matthew MacCumber. I'm a professor at Rush University Medical Center in Chicago and a member of Illinois Retina Associates. And I'm going to going to be discussing a lecture I gave at the Retina Society meeting this year in New York. The title is 0.19 mg Fluocinolone Acetonide (FAc) Implant, or Iluvien, and how it can improve vision and treatment burden in patients with diabetic macular edema.

So now, the PALADIN study was a phase 4, 3-year observational prospective safety study of 202 eyes with diabetic macular edema from 159 patients. It's a real-world safety study, but we also looked at secondary outcomes including visual acuity changes and treatment frequency. Prior to injection of Iluvien, in the study, visual acuity declined in a retrospective analysis on average 6.4 letters in eyes in the study. And prior to the Iluvien implantation, eyes were receiving on between 0 and greater than 5 treatments a year, but most eyes receive, received 3 to 5 treatments per year. After they receive the Iluvien implant in the study, the vision improved over 3 years by, on average, 4.5 letters, and in fact, the number of additional treatments declined compared to prior to PALADIN with almost 70% of eyes needing only 0 to 2 supplemental treatments. The reduction in mean number of treatment actually was apparent even at 6 months into the study after the Iluvien injection and by 3 years, eyes were receiving on average about 1.7 treatments per year.

A Kaplan Meier analysis showed that out to 3 years, 25% did not need to receive any supplemental treatments, and there was reduction in laser treatments, anti-VEGF treatments, as well as steroid treatments. And I should remind everyone that no treatments were required and, and there was no limitation on treatments. It was, they were all up to the investigator discretion. One other finding was that eyes that had fewer IOP related events were, in general, those that required the less supplementation.

So in fact, eyes that were healthier in a sense, because they had fewer IOP events, in fact, had fewer supplemental injections. So in fact, if we look at IOP elevation, greater than 25 millimeters of mercury. It this occurred in 18% that had no supplemental treatments where it was 27% that had supplemental treatments and 36% that needed a steroid supplemental treatment. If we also look at incisional IOP, lowering surgery, only 2 eyes needed that in the group that required no supplemental injections and 1 of these was due to neovascular Glaucoma. Whereas eyes that receive supplemental treatments, there were 6 that needed incisional surgery, and 2 of these were due to neovascular Glaucoma.

So I can summarize results by saying that the best corrected visual acuity was significantly increased by 4.5 letters on average, in almost 70% of eyes, I'm sorry, overall, and an almost 70% of eyes required 0 to 2 yearly treatments after Iluvien implantation, whereas prior to the study, prior to Iluvien, there was a 6.4 letter loss on average, and eyes were receiving over, and most eyes were receiving over 3 yearly treatments. So the treatment burden was reduced and in fact that was evident even at 6 months. One quarter of patients require no supplemental therapy by3 years, and eyes that did not require additional treatments experienced fewer IOP related safety events than is receiving additional anti-VEGF steroid or laser therapies.

Sydney M. Crago: How this may impact retinal care going forward?

Mathew MacCumber, MD, PhD, FASRS: Well, I think this study provides some real-world evidence that Iluvien can be effective in decreasing treatment burden and helping vision and patients who have diabetic macular edema. And will be, and these were eyes that had previously had treatment. We are looking at eyes that have not had previous treatment and the NEW DAY study. So Iluvien might even be a primary therapy, but we'll, we'll know, learn more about that from NEW DAY. So right now it is useful, I would say, secondary therapy and if other therapies are not adequate.

Sydney M. Crago: Excellent. Thank you so much, and thank you for your time today.

athew MacCumber, MD, PhD, FASRS: My pleasure.