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The results were presented at a symposium during the American Diabetes Association's 84th Scientific Sessions in Orlando, Florida, and mark the first large-scale trial specifically designed to investigate the effect of fenofibrate on eye outcomes in people with early diabetic retinopathy.
Results from the Lowering Events in Non-proliferative retinopathy in Scotland (LENS) Trial have revealed that fenofibrate, a medication used for many years to reduce blood fat levels, significantly reduces the progression of diabetic retinopathy, a diabetes-related eye disease.
The findings were delivered by delivered by Oxford Population Health. According to a news release,1 this marks the first large-scale trial specifically designed to investigate the effect of this drug on eye outcomes in people with early diabetic retinopathy. The results were presented at a symposium during the American Diabetes Association's (ADA) 84th Scientific Sessions in Orlando, Florida, and were published in NEJM Evidence.
Diabetic retinopathy is a leading cause of visual loss around the world, with increasing instances in many regions of the world over the last 3 decades.2 Effective management of blood glucose levels is key to reduce the risk of disease progression, but this can be difficult to achieve for many patients and there are no other treatment options available for people with early retinopathy.
According to the news release, the LENS Trial sought to address this challenge by evaluating the impact of an existing solution for high cholesterol on diabetic retinopathy outcomes.
The researchers noted the randomly assigned controlled trial was conducted within Scotland's Diabetic Eye Screening (DES) program, a national scheme that provides regular retinal imaging to all patients with diabetes, aged 12 years or more, across the country.1
As part of the trial, 1151 adults with early diabetic retinopathy or maculopathy were assigned to receive either 145 mg fenofibrate tablets or placebo. According to the research, the primary outcome was a composite measure of developing referable diabetic retinopathy or maculopathy (i.e. a grading of diabetic eye disease that warrants specialist ophthalmic review) or requiring treatment with laser, intravitreal injection or vitrectomy.
Researchers found that that fenofibrate could be an effective option for people with early diabetic retinopathy. Over the course of 4 years, participants taking fenofibrate saw a 27% reduction in the progression of their eye disease compared to those taking the placebo (22.7% vs. 29.2%), a result that was highly statistically significant (p=0.006).1
Moreover, fenofibrate reduced the chance of any progression of retinopathy and it cut the risk of developing macular edema.
"Diabetic retinopathy remains a leading cause of visual loss and we need simple strategies that can be widely used to reduce the progression of diabetic eye disease," David Preiss, PhD, MRCP, FRCPath, associate professor at Oxford Population Health, said in the news release. "Results from the LENS trial suggest that fenofibrate may provide a valuable addition to treat people with diabetic retinopathy."
By running the trial in partnership with the Scottish DES, the LENS investigators were able to collect 9000 retinal images and these will be analyzed using machine learning tools to better understand the effect of fenofibrate in the diabetic eye. The researchers will continue to track participants' progress through linkage to national health records to understand the long-term impacts of fenofibrate therapy on health.1