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.
Why have I been invited?
If you have received an invitation from the lead NHS specialist for diabetic retinopathy in your health board it means that your recent retinal screening results indicate that there is a good chance that you may be eligible to take part in the LENS trial. We are keen to offer as many people as possible the chance to take part.
Do I have to take part?
No. Participation is entirely up to you. If you agree to take part we will ask you to sign a form to record your consent. You are free to withdraw from the trial at any time, without giving a reason and this will not affect your NHS in any way. If you choose to take part, your GP will be informed.
Who is running and who is funding the trial?
LENS is being led by experienced doctors and researchers at the Universities of Oxford, Glasgow, Dundee, Edinburgh and Aberdeen. The trial is funded by the National Institute for Health Research (NIHR), which is funded by the Department of Health. The NIHR exists to improve the health of the nation through medical research. Treatment for this trial has been obtained from Mylan (a pharmaceutical company), however the company plays no other role in the trial. LENS results will be analysed by researchers at the University of Oxford.
What are the benefits of taking part in this trial?
While there may be no benefit for you, you will be helping doctors and scientists improve treatment for people who have diabetes and who may be at risk of serious eye disease. If successful, results from this trial will allow fenofibrate to be used for patients with retinopathy worldwide. We also know from previous studies that fenofibrate may provide other benefits. For example, the medicine reduces the chance of having a heart attack by 10-15%. Your other diabetes care and any treatment you may require for diabetic retinopathy will not change.
Are there any risks?
Most treatments have side-effects which some people may experience and others may not. Fenofibrate is usually well tolerated with no serious safety problems. The ‘run-in phase’ will also give us a good chance to check that you have no problems with the tablets. We will send you a questionnaire every 6 months which specifically asks about your recent health. In addition, the research team will monitor your medical records regarding any admissions to hospital and any routine blood tests which you have. You can withdraw from the trial at any time if you wish and this will have no impact on your usual NHS care.
Fenofibrate is a licensed drug in the UK for treating people with raised cholesterol levels but it is not currently licensed for treating diabetic retinopathy. In LENS we are testing whether fenofibrate should be used as a treatment for patients with diabetes and retinopathy. Fenofibrate can be taken safely regardless of whether you are on a statin or not, as already confirmed in major studies. It is also safe to take with the vast majority of other medicines. We will check that you are not on any medicines which cannot be taken with fenofibrate. It is well known that treatment with fenofibrate often causes a small rise in a blood test called creatinine, which is a test of kidney function. However, creatinine then quickly returns to one’s normal level when fenofibrate is stopped, so there is no evidence that using fenofibrate harms the kidney in any way. You will receive a Treatment Information Leaflet with more details before entering the ‘run-in’ phase.
In large trials of fenofibrate and similar drugs (called fibrates), those treated with fibrates had a lower risk of suffering heart attacks and foot amputations.
If you do experience side effects, you may choose or be advised by your doctor to stop the trial tablets. There is nothing to suggest that stopping the tablets will cause you any harm. If you experience unexpected symptoms after joining the trial you can contact your LENS research nurse, or a trial doctor on Freephone 0808 164 5090 (available 24 hours a day, 7 days a week).
The effects of fenofibrate on the unborn child and on children being breast-fed are not definitively known. For this reason fenofibrate should not be taken by women who are pregnant, planning to become pregnant, or breast feeding, and these women cannot take part in the trial. Women who could become pregnant must use effective and reliable contraception during the study and for 7 days after the end of the study (i.e. after stopping study treatment). If you become pregnant during the trial (or plan to become pregnant), you should tell your research nurse or the LENS trial doctors immediately so appropriate steps can been discussed.
What happens when the trial stops?
Once the trial is over you will no longer be provided with the trial treatment. You and your doctor will be informed of the results which will also be published in a medical journal, so that others can benefit from the research. If the trial proves that fenofibrate does reduce diabetic retinopathy, it is likely that this information will be included in major guidelines which doctors use to treat diabetes. That will allow many people with diabetes to be offered fenofibrate.
After the trial ends, we would also like your permission to continue to monitor your health confidentially from a range of medical records using existing electronic systems in the same way that we will be doing during the trial. This is to allow the LENS researchers to study the effect of 3-5 years of fenofibrate treatment for many years to come. Permission will be required from NHS Scotland’s Public Benefits and Privacy Panel for Health and Social Care before any such work is undertaken to ensure that it is done to the highest standards and in accordance with the Data Protection Act.
What if relevant new information becomes available?
Sometimes, during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, the research team will tell you about it and discuss whether you want to, or should, continue in the trial. If you decide not to carry on, your research nurse will make the necessary arrangements. Upon receiving new information, your own doctor might consider it to be in your best interests to stop the trial treatments. They will explain the reasons if this needs to happen. If the trial is stopped for any other reason, you will be told why.
What if I don’t want to carry on with the trial?
If you wish to discontinue your trial treatment we would advise you to do this in consultation with the LENS research team. However we’d still like to send you questionnaires to ensure the trial’s results are reliable. You are free to completely withdraw from the trial at any time in which case you will not receive any further questionnaires.
For women: Women who could become pregnant must continue to use effective methods of contraception for 7 days after stopping trial treatment (or the end of the study).
What if there is a problem?
You retain all the usual rights of an NHS patient. The University of Oxford, which is sponsoring the trial, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in the trial. If you have a concern about any aspect of the trial you can speak with the LENS researchers. They can be contacted on a 24-hour Freephone number: 0808 164 5090 or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 572224 or the head of CTRG, email email@example.com. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the Patient Advice and Support Service (however, this service is unable to provide information about this trial) at: http://www.patientadvicescotland.org.uk/
Will my taking part be kept confidential?
Yes, absolutely. If you accept this invitation, your contact details will be stored securely so that further information can be sent to you (these details can only be seen by your local research team and by staff working in the co-ordinating centres at the Universities of Oxford and Glasgow). The central co-ordinating centre in Oxford will seek information from NHS and other central registries about any serious illnesses, your retinal screening results and blood results taken as part of your usual care. The central co-ordinating centre may also contact your own doctor if any further information is required. For these reasons we require your name, date of birth and CHI number (this is your unique number in the NHS).
All information obtained will be kept confidentially and only used for medical research. Your personal details will never be transferred to any other party. Responsible members of the University of Oxford, your host NHS health board, or regulatory authorities may be given access to data for monitoring and/or audit of the study to ensure compliance with regulations. Information used for scientific analyses will never include any details that identify you.
What will happen to the results of the research trial?
It is intended to present the results at a major medical conference and publish them in an appropriate medical journal. No patient will be individually identified in any report or publication.
What travel expenses are available for the two clinic visits?
We will reimburse reasonable expenses for travelling to your LENS appointments. Please make sure you ask about this at the clinic. Taxi travel will also be provided if needed.
How is this trial organised?
Scientists and doctors consider the question being asked by LENS important because it could improve treatment for people who have diabetes by reducing the risk which retinopathy poses to vision. Scientists at the University of Oxford are co-ordinating the study with the collaboration of the Universities of Glasgow, Aberdeen, Edinburgh and Dundee, and with doctors and nurses from around Scotland. The trial design has been reviewed and agreed by the West of Scotland Research Ethics Committee whose duty it is to check whether the health question being asked is important enough to warrant a trial, and that the trial is being carried out in an independent, honest and professional manner.
An independent committee oversees the study and monitors the results. This committee could stop the trial early if important new evidence emerged that had an impact on the need for the trial to continue.