Your session is about to expire
← Back to Search
Fenofibrate for Diabetic Retinopathy (Protocol AF Trial)
Protocol AF Trial Summary
This trial will compare the effect of fenofibrate (a drug used to treat high cholesterol) to placebo for preventing diabetic retinopathy (a disease that affects the retina) from getting worse. The trial will also assess the relationship of glycemic variability (how much blood sugar levels fluctuate) with diabetic retinopathy outcomes.
Protocol AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowProtocol AF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 551 Patients • NCT03001817Protocol AF Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- It seems like the criterion you provided is incomplete. Can you please provide more details or context so that I can assist you accurately?I am between 18 and 79 years old.I am between 18 and 79 years old.My non-study eye has minor blood vessel damage.My kidney function is normal or only mildly reduced, not requiring dialysis.Your eyesight with glasses or contacts is at least 20/32 or better, unless there are specific eye conditions that might affect your vision.I have diabetes.You have a specific eye condition called CI-DME, based on an eye exam or OCT scan with certain measurements for CST.I haven't had eye injections for any condition in the last year.I have not had any treatments for my diabetic eye condition except possibly for laser treatment over a year ago.I have diabetes.I have mild to moderate diabetic retinopathy in at least one eye.My eye condition is between mild and moderately severe non-proliferative diabetic retinopathy.
- Group 1: Fenofibrate 160-mg
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA sanction Fenofibrate 160mg?
"Fenofibrate 160mg receives a safety rating of 3 due to Phase 3 clinical trial data, which demonstrates both efficacy and safety."
Are investigators actively looking for participants for this research?
"The aforementioned clinical trial, as seen on clinicaltrials.gov, is looking for volunteers. This trial was originally posted on 3/5/2021 and was updated as recently as 10/13/2022."
Are there other areas of research where Fenofibrate 160mg is being studied?
"The efficacy of fenofibrate 160mg was first researched in 2009 by University of Ioannina Medical School. In the years since, a total of 18314 clinical trials have been completed. Fenofibrate is currently being trialled in 9 active studies, the majority of which are based in Ayer, Massachusetts."
To whom does this study apply?
"This clinical trial is accepting 910 participants, between the ages of 18 and 80 who currently have diabetic retinopathy. It is required that patients also meet the following criteria: Key Inclusion Criteria, Age ≥18 years and < 80 years., Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs., If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20), Key, Type 1 or type 2 diabetes., Best-corrected E-ETD"
What is the most frequent reason that Fenofibrate 160mg is prescribed?
"Fenofibrate 160mg is an effective treatment for patients with conditions including hypertriglyceridemia, severe fredrickson type v hypertriglyceridemia, and dyslipidemias."
How many different medical clinics is this research being conducted in?
"There are 49 sites running this clinical trial, including Valley Eye Physicians and Surgeons in Ayer, University of North carolina at Chapel Hill in Chapel Hill, and Vitreo-Retinal Associates in Grand Rapids, as well as a number of other locations."
Can elderly patients participate in this research?
"This particular clinical trial is only open to individuals between 18-80 years old. However, there are 29 active trials for those under 18 and 111 for seniors above 65."
How many patients are being treated in this study?
"That is correct, the clinical trial is currently looking for 910 patients from 49 locations. The trial was posted on March 5th, 2021 and was last updated on October 13th, 2022."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Share this study with friends
Copy Link
Messenger