At ASRS in New York, Matthew Starr, MD, presented, “Factors Associated With Fluctuations in Central Subfield Thickness in Patients With Diabetic Macular Edema Using 2 Clinical Trial Databases.”
Sheryl Stevenson [SS]: We're here with Dr. Matt Starr, thank you so much for sharing some of your pearls of your talk today with us.
Matthew Starr, MD [MS]: Yeah, so this is a segue project that we took from last year’s presentation ASRS. When we identify patients with worse vision, it's with fluctuations in their central subfield thickness and the DRCR Protocols T and V. And what we did last year, we didn't really look at any metrics that were associated with worse fluctuations in central subfield thickness and diabetic patients.
And so this year now at ASRS, we're going to be presenting our new data, which we looked at risk factors for patients who develop CST or central subfield thickness fluctuations over time, and the DRCR Protocols T and V.
So we again, you have the publicly available datasets. Again, the DRCR had no role in this project, but they had that publicly available data. We took the standard deviation for all of the CSTs for each study patient, there are about 14 and 20 in each of the studies respectively. So we had a good number of measurements for each patient. And then we analyzed the baseline and ocular and systemic risk factors using a multivariate regression analysis. And so we did a few predictions of statistical analysis looking for anything that we could identify that may lead a patient to have—more prone to have CST fluctuations.
And we have almost 1200 eyes in this analysis. When we looked at the multivariate regression analysis, we were controlling for baseline, your age, gender, CST status, Amina hemoglobin, A1C, renal status, co-vision—we controlled for a lot of different metrics.
And we looked for, you know, does kidney status, does mean CST status, this treatment algorithm, age, you know, type of diabetes, do those kinds of things affect whether or not a patient is more prone to have more frequent fluctuations in their diabetes or their diabetic macular edema?
And so what we did find is that patients with worse vision at baseline, worse baseline renal disease—so not necessarily the creatinine, but having an elevated albumin to creatinine ratio—was actually statistically significant for having your worst CST fluctuations. Additionally, having a history of hypertension, you know, female gender, type one diabetes versus type two, were more, were prone to have CST fluctuations.
And lastly, it's a little bit controversial, but delaying anti-VEGF treatment was also associated with higher fluctuations in CST. So protocol V, where they either opted for a prompt late anti-VEGF or focal laser or observation, that's where we're getting that answer from. Although in Protocol V, there was really no statistical difference in vision that they found in their study, whether you have two years whether you're injected right away or observed, we're finding that perhaps these patients that are observed may have more fluctuations in their central subfield thickness. And that makes sense. If you observe someone, you may see their CST go up and down. What is the significance of that? You know, we speculated that perhaps if you have more CST fluctuations, you may have your worst vision, and we did find a hint of that at our last study. But again, in Protocol V, there was those difference in vision.
So, you know, the meaning of that is still to be determined, but I think there is some noise to that. And, you know, further studies, you're going to be looking at a little more long-term, you know, assessment of the CST fluctuations.
SS: And what are you most excited about or looking forward to at this year's ASRS?
MS: Just, you know, really excited to be back together with everyone in New York City. I can't wait to see all my friends and colleagues from other institutions and get to hear all the great things that everyone's working on. Really interested in seeing some of the new data for what anti-VEGF treatments are holding, you know, the surgical studies. You know, there's a lot of good things coming out in retina right now and there's a lot to be excited for this year's meeting. Thank you so much for having me. I really look forward to seeing everyone in New York.
Note: This transcript has been lightly edited for clarity.