What is the purpose of the trial?
Diabetes can affect the small blood vessels at the back of the eye, a condition called diabetic retinopathy. Diabetic retinopathy remains one of the main causes of blindness and poor vision in adults of working age, which is why NHS Scotland offers everyone with diabetes retinal screening. Retinal screening involves taking photographs of the back of the eyes (or retina) every 6 to 24 months, so that any changes caused by diabetes can be monitored. Good control of blood sugar and blood pressure reduces the chances that diabetic retinopathy will become severe. However, the condition is often progressive and patients may still need specialist NHS treatment such as laser therapy, surgery, or courses of injections to the eyes to preserve their vision. Each year, 5,500 patients with diabetes in Scotland need to see a NHS eye specialist because of worsening retinopathy. It is important therefore to find and develop simple, effective treatments that slow down or stop the progression of retinopathy.
The LENS (Lowering Events in Non-proliferative retinopathy in Scotland) trial is investigating whether taking a drug called fenofibrate will slow down the progression of diabetic retinopathy.
Fenofibrate is a tablet that has been used to lower cholesterol for over 30 years. Two large studies have suggested that this medicine may slow down the progression of retinopathy. We are conducting the LENS trial to find out if fenofibrate should be routinely used in patients with retinopathy to stop the condition from getting worse. Approximately 1,100 patients from across Scotland known to have diabetes and retinopathy will take part. With their approval, their health will be followed during the trial. This will be done accurately and confidentially from a range of medical records using existing electronic systems. It will be done safely and securely in accordance with the Data Protection Act. Permission has been obtained from NHS Scotland’s Public Benefits and Privacy Panel for Health and Social Care to ensure that the trial is done to the highest standards.