In 1994, the Centers for Disease Control and Prevention (CDC) declared diabetes mellitus an epidemic. By 2021, 1 in 10 adults worldwide had diabetes. One in 5 Americans over age 65 had diabetes. One in 3 American adults had impaired glucose tolerance and were prediabetic. Look to your left and right; one of you will have diabetes shortly. Now I have your attention!
Much of the epidemic is due to increased prevalence of type 2 diabetes (90% to 95% of all diabetics), which is largely due to modifiable risk factors. Type 2 diabetes has even been referred to as the “modern preventable pandemic” to spur governments to enact health policy and funding to fight it, like we did the COVID-19 pandemic. With a 75% increase in cardiovascular disease mortality in diabetics, why has so little been done? Zimmet even called it the “diabesity” epidemic and went as far as calling diabesity the biggest epidemic in human history.1 Hyperbole? Maybe, but not too far off.
Alarmingly, the global prevalence of type 2 diabetes has tripled over the past 20 years and shows no signs of slowing down. This has obviously led to an explosion of patients with diabetic retinopathy (DR). In 2021, around 26% of diabetics in the United States had diabetic retinopathy, with 5% having vision-threatening DR. Interestingly, the highest rate was in Massachusetts with DR in 33% of diabetics.2
The landmark Early Treatment Diabetic Retinopathy Study (ETDRS) in the 1980s ushered in a new era in clinical trial design and understanding of diabetic eye disease. From using lasers and surgery to treat DR when I was in training, we moved into the anti-VEGF era that has revolutionized our ability to prevent blindness. We are now looking at a new chapter of gene therapy delivered with an in-office injection that may prevent DR from ever worsening. Pills and even eye drops are being tested to combat this disease. In fact, there are an exploding number of companies looking at treating DR with a variety of mechanisms of action. The next generation of medications cannot come fast enough, because the number of people who need it is only increasing.
To increase the pace of new drug approvals, the Food and Drug Administration and researchers are looking at different clinical trial outcomes beyond the 60-year-old Diabetic Retinopathy Severity Scale used for every approval to date. Unlike this scale, which only relies on color photographs, newer endpoints use modern imaging devices. In this issue, we explore these new clinical trial endpoints and imaging modalities and how they can be used to monitor DR.
The sad truth about the state of DR therapy is that we are focusing on new treatments and ways to diagnose DR instead of ways to prevent it. It truly is a diabesity epidemic that hopefully will obtain funding to reduce prevalence rates in our future. RP
References
1. Zimmet PZ. Diabetes and its drivers: the largest epidemic in human history? Clin Diabetes Endocrinol. 2017;3:1. doi:10.1186/s40842-016-0039-3
2. Lundeen EA, Burke-Conte Z, Rein DB, et al. Prevalence of diabetic retinopathy in the US in 2021. JAMA Ophthalmol. 2023;141(8):747-754. doi:10.1001/jamaophthalmol.2023.2289
