New Trial Testing Cholesterol Drug To See Impact on Diabetes-Related Retinopathy
If you have type 1 or type 2 diabetes and are between 18-80 years old, you may be eligible to join a trial studying whether the drug fenofibrate can prevent the worsening of diabetes-related retinopathy.
Clinical Trials Identifier: NCT04661358
Trial Name: Fenofibrate for Prevention of DR Worsening (Protocol AF)
Diabetes Type: Type 1 and type 2 diabetes
Trial Sponsor: Jaeb Center for Health Research
What is the aim of the study?
The study is evaluating whether fenofibrate, an oral medication used to lower high cholesterol and triglycerides (fat) in the blood, can help prevent the worsening of non-proliferative retinopathy.
Also being studied is whether ophthalmologists would prescribe or coordinate with an internist or endocrinologist to prescribe and monitor use of the drug.
Previous research has shown fenofibrate can be effective at reducing the need for laser treatments for diabetes-related retinopathy, which requires the expertise of ophthalmologists.
How does the trial work?
Participants in the study with moderate to severe non-proliferative retinopathy will be given a 160 mg or 54 mg dose of fenofibrate – or a placebo – and followed for six years.
Researchers are interested in determining if the widespread use of this medicine could be effective at reducing diabetes-related retinopathy. If so, people with this chronic condition could avoid more invasive and expensive treatment. In addition, halting the progression of retinopathy could help avoid further negative effects on visual function, including vision loss.
The study will also evaluate if fenofibrate has an effect on the variation of blood sugar levels throughout the day.
Are you interested in participating?
You may be able to join the trial if you meet the following criteria:
- Age 18 to 80 years old
- Type 1 or type 2 diabetes
- At least one eye with the following:
- Mild to moderately severe non-proliferative retinopathy (defined by ETDRS DR severity level 35 to 47)
- Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best-corrected letter score is 74-78, the investigator must verify that vision loss is not due to the presence of CI-DME, cataracts, or other condition that may affect visual acuity during the study.
- If only one eye is eligible, the non-study eye must have at least microaneurysms only (diabetic retinopathy severity level 20)
The trial is currently recruiting in several locations throughout the U.S. See a full list of inclusion/exclusion criteria here.
Learn more about diabetes-related eye conditions: