What happens during the trial?
At your first visit, the trial will be explained to you in more detail and you will be given plenty of opportunity to ask questions. A trained nurse will check your medical records to ensure you meet the entry criteria to take part. If you are interested in the trial and are likely to be suitable, you will be asked to sign a form agreeing to take part. The nurse will ask you about your medical history and will also take a sample of blood (you do not need to fast) to check your kidney and liver functions, cholesterol and HbA1c and, if possible, a sample of urine will also be taken. These samples will be tested in the hospital’s NHS laboratory to make sure that you are suitable to take part.
You will complete two questionnaires with the nurse, one about your quality of life and the other about your eyesight. The visit will last about 60 minutes. When the research nurse receives your blood test results a few days later, you will be contacted to let you know if you are eligible to continue. If eligible, you will enter the ‘run-in’ phase of the trial. This is an 8 week period which will allow you and the LENS doctors and nurses to be sure that you are happy to take fenofibrate tablets and that they agree with you. You will receive the fenofibrate tablets by post along with instructions about how to take them.
After 8 weeks
After taking the fenofibrate tablets for about 8 weeks you will be asked to attend a second appointment (of about 45 minutes) at the same place. If you have had no problems with the trial treatment during the previous few weeks, have taken them regularly and are happy to continue, you will be asked to commit to the trial for at least the next 3 years. Your height, weight and blood pressure will be checked and another blood sample will be taken. A few days after the visit, once the research nurse receives these blood results, you will be contacted to confirm whether or not you are suitable to continue in the trial.
The rest of the trial
If you continue, you will receive regular supplies of trial tablets by post. You will be provided with either fenofibrate tablets (the drug being tested) or ‘dummy’ placebo tablets to take for the rest of the trial. You are assigned fenofibrate or the dummy drug ‘at random’ (like the toss of a coin) which allows us to properly test whether the fenofibrate works. You have as much chance of receiving fenofibrate as you do of receiving the dummy tablet. You will not know which treatment you receive, nor will your GP or the LENS staff. However, this information would be made available to your doctor and other medical staff if it was medically necessary.
You will not need to attend the research clinic again. Trial tablets will be sent to you by post every 6 months and you will be asked to complete trial questionnaires over the ‘phone or on your computer every 6 months.