News

lens results: Cholesterol-lowering drug slows progression of eye disease in people with diabetes

The LENS trial has demonstrated that fenofibrate, a drug usually used to lower cholesterol, reduces the risk of progression of diabetic retinopathy by 27%. The results were announced today at the American Diabetes Association Scientific Sessions and published in NEJM Evidence.

Diabetes can cause damage to the small blood vessels at the back of the eye, a condition called diabetic retinopathy. Diabetic retinopathy is among the top five causes of visual loss worldwide and the only major cause to increase in recent decades.

Fenofibrate is a tablet that has been used to lower cholesterol for more than 30 years. Previous results from sub-studies of trials looking into treatments for heart disease had suggested that fenofibrate might be able to slow the progression of diabetic retinopathy but more conclusive results were needed.

Coordinated by Oxford Population Health, the LENS (Lowering Events in Non-proliferative retinopathy in Scotland) trial compared the effects of fenofibrate with a placebo (dummy tablet) on the progression of retinopathy in 1,151 adults with type 1 or type 2 diabetes in Scotland as part of the national routine diabetic eye screening programme. All of the participants had early to moderate diabetic retinopathy when they joined the trial.

Key findings:

People who received fenofibrate had a 27% lower risk of needing to be referred for specialist care or treatment for diabetic retinopathy or maculopathy (a progressive eye disease that can lead to vision loss) over four years compared with people who were assigned to receive a placebo;
Treatment with fenofibrate was also associated with a lower risk of developing macular oedema (swelling at the back of the eye) and a lower risk of requiring treatment for retinopathy compared to placebo;
The benefits of fenofibrate were similar in people with both type 1 and type 2 diabetes, and in people with both normal and impaired kidney function.

Dr David Preiss, Associate Professor at Oxford Population Health and lead author of the study, said ‘Diabetic retinopathy remains a leading cause of visual loss. Good control of blood glucose is important but this is very difficult to achieve for many people, and there are few other treatments available. We need simple strategies that can be widely used to reduce the progression of diabetic eye disease. Fenofibrate may therefore provide a valuable addition to treat people with early to moderate diabetic retinopathy.’

Melville Henry, a LENS trial participant from Leven, said ‘Taking part in the trial was very easy; there was nothing to it really. I just had to follow the instructions and take the study tablets. I attended my local research clinic appointments at first and then I had regular telephone calls to ask about my progress.’

Linda Gillespie, a LENS trial participant from Kirkcaldy, said ‘I attended the clinic for diabetic eye screening anyway so taking part in the trial was extremely easy, I never had to think about it. If I had any questions, someone was always at the end of the phone. It was really important to me to take part in research because without trials like LENS we can’t move forward. The results of the trial might not help me but it might help someone else in the future.’

Dr Lucy Chambers, Head of Research Communications at Diabetes UK, said ‘Eye problems are a frightening and too frequent complication of diabetes. But acting early can stop the first signs of damage progressing into devastating sight loss. We’re excited by the positive results from this major trial of a new treatment to slow progression of eye damage, which has the potential to benefit many people with diabetes in the UK.’

LENS is being coordinated by Oxford Population Health, and was run in close partnership with the Universities of Glasgow, Aberdeen, Dundee and Edinburgh, and with NHS Scotland’s Diabetic Eye Screening Service. It was funded primarily by the National Institute for Health and Care Research’s Health Technology Assessment Programme.

LENS results will emerge on Friday 21 June 2024

The key results from the LENS trial will be presented at the American Diabetes Association's annual conference on Friday 21 June 2024. We will mail newsletters to all LENS participants, summarising the results, shortly thereafter.

FINAL FOLLOW UP CALLS COMPLETED

Final follow up calls have been completed, and the Coordinating Centre in Oxford has now received the final NHS linkage data for all LENS participants. Results for the trial will emerge in mid-2024.

FINAL FOLLOW UP CALLS FROM JULY TO SEPTEMBER 2023

When we designed LENS, we knew that the trial needed to include enough participants and continue for long enough to reliably tell us whether treatment with fenofibrate is beneficial—in other words, if fenofibrate reduces the number of people with diabetic retinopathy who go on to develop significant eye disease. The trial will continue until the second half of 2023 to achieve this.

From 17 July 2023, participants will have their final LENS call with one of the research nurses. A few weeks before this, we will also send participants the two paper questionnaires (about vision and quality of life) by mail to complete one last time.

INTERNATIONAL CLINICAL TRIALS DAY 2022

May 20th is International Clinical Trials Day. This is the anniversary of the date in 1747 when James Lind, a surgeon's mate on the HMS Salisbury, started what is often considered the first clinical trial, testing whether various treatments might be beneficial for sailors suffering from scurvy. It is a timely reminder of the value of randomised trials such as LENS. Some of the important features of trials are discussed in this article on the Oxford Population Health website.

RECRUITMENT INTO THE LENS TRIAL IS COMPLETE!

Congratulations to NHS Forth Valley who enrolled the final participant to join the LENS trial (on 27 July 2021). Our amazing sites have randomized 1151 participants between them across all mainland NHS Scotland Health Boards.

THE CHALLENGES OF CONDUCTING CLINICAL TRIALS DURING A PANDEMIC

You may be interested to read the article by Dr Caroline Wood (University of Oxford) which describes some of the challenges that have arisen conducting clinical trials of treatments for chronic disease in the time of COVID-19. Various features of the LENS trial, and the heroic efforts of the study team in Oxford and across Scotland, have meant that the study has continued to progress well despite these difficult circumstances.

questionnaires on visual function and quality of life

Participants who have been taking part in LENS for over two years will receive a couple of questionnaires in the post. The first questionnaire (called the VFQ-25) asks about your vision. The second questionnaire (called the EQ-5D) asks about your quality of life. These are the same questionnaires that you completed at the very start of the trial.

The information that we collect in these forms is very important to the trial, and we greatly appreciate you taking the time to complete them and send them back to us by FREEPOST. If you have any questions about how to complete either of the questionnaires, please do not hesitate to give us a call. Thank you for your ongoing support for LENS.

Newsletters

INSIGHT: LENS Trial newsletter number 5, June 2024

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