Fenofibrate, a commonly prescribed medication for treating high cholesterol and high triglyceride levels, has been shown to significantly reduce the progression of diabetic retinopathy, according to findings from the Lowering Events in Non-proliferative retinopathy in Scotland (LENS) trial, which were presented during the symposium Systemic Medications for Diabetic Retinopathy—Protective and Risk Factors on Friday, June 21, at the 84^th Scientific Sessions.

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“Diabetic retinopathy is one of the top five leading causes of visual loss in the world, and it is the only one that has increased in a number of regions of the world in the last three decades,” said LENS Principal Investigator David Preiss, MBChB, MRCP, FRCPath, PhD, University of Oxford, United Kingdom, who presented the results.

While there are established treatments for advanced retinal disease, there are currently no approved pharmacological interventions that have proven effective in treating the early stages of eye disease and preventing or delaying the progression to advanced disease, he said. Previous findings from a number of cardiovascular trials suggested the potential of fenofibrate in treating diabetic retinopathy and informed the hypothesis for the LENS trial.

The Phase 4 randomized controlled trial was conducted within Scotland’s Diabetic Eye Screening (DES) program, a national program that provides regular retinal imaging to all patients with diabetes, aged 12 years or more, across the country. The trial included 1,151 adults with diabetes of any type except gestational diabetes and with observable early diabetic retinopathy or maculopathy. Participants were assigned to receive either 145 mg fenofibrate tablets or placebo. The primary outcome was a composite measure of developing referable diabetic retinopathy or maculopathy or requiring advanced disease treatment with laser, intravitreal injection, or vitrectomy.

Dr. Preiss reported that, over the four years of the trial, participants taking fenofibrate saw a greater reduction in the progression of their eye disease compared to those taking the placebo—with 22.7 percent of those taking the drug experiencing referable disease or treatment versus 29.2 percent of those taking the placebo—a result that was highly statistically significant (p=0.006). The benefits, he noted, appeared similar across the various prespecified subgroups in the study.

“We also observed reductions in any progression of retinopathy and in macular edema,” Dr. Preiss said. “Overall, our results do appear very similar quantitatively to hypothesis-generating results from cardiovascular trials.”

Moving forward, he said the methodology employed in the LENS trial effectively demonstrates how large retinal screening programs can be harnessed to conduct randomized trials.

Other speakers during the symposium included Andrew J. Barkmeier, MD, of the Mayo Clinic, who discussed the role of systemic pharmacotherapy in the prevention and management of diabetic macular edema; Alicia Jenkins, MBBS, MD, FRACP, FRCP, Baker Heart and Diabetes Institute, who shared data from the ongoing FAME 1 Eye trial looking specifically at the potential benefits of fenofibrate in adults with type 1 diabetes; and Satish K. Garg, MD, University of Colorado, Denver, who discussed the effects of glucagon-like peptide-1 (GLP-1) receptor agonists on diabetic retinopathy.