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Fibrate

Fenofibrate for Diabetic Retinopathy (Protocol AF Trial)

Phase 3
Recruiting
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Age ≥18 years and < 80 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

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.

Who is the study for?
Adults aged 18-79 with type 1 or type 2 diabetes and mild to moderately severe non-proliferative diabetic retinopathy (NPDR) in at least one eye can join. They must have good vision (20/32 or better) and no current diabetic macular edema (DME). Those with previous treatments for DME or DR, except certain lasers, poor kidney function, or recent anti-VEGF/corticosteroid eye injections cannot participate.Check my eligibility
What is being tested?
The trial is testing if fenofibrate can prevent the worsening of diabetic retinopathy over four years compared to a placebo. It's randomized, meaning participants are put into the fenofibrate or placebo group by chance. The study also explores how doctors might safely prescribe this treatment.See study design
What are the potential side effects?
Fenofibrate may cause side effects like liver enzyme increases, muscle tenderness or weakness, abdominal pain, nausea, headache and increased risk of pancreatitis and gallstones. However, individual experiences may vary.

Protocol AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It seems like the criterion you provided is incomplete. Can you please provide more details or context so that I can assist you accurately?
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I am between 18 and 79 years old.
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I am between 18 and 79 years old.
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My non-study eye has minor blood vessel damage.
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I have diabetes.
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I have diabetes.
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I have mild to moderate diabetic retinopathy in at least one eye.
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My eye condition is between mild and moderately severe non-proliferative diabetic retinopathy.

Protocol AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diabetic Retinopathy
Secondary outcome measures
Development of CI-DME
Development of center-involved diabetic macular edema with vision loss
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
+1 more

Side effects data

From 2019 Phase 3 trial • 551 Patients • NCT03001817
1%
Nasopharyngitis
1%
Angina unstable
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fenofibrate and K-877 Placebo: 40-Week Extension
K-877 and Fenofibrate Placebo: 40-Week Extension
K-877: 12-Week Efficacy
Placebo: 12-Week Efficacy

Protocol AF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fenofibrate 160-mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate
2018
Completed Phase 4
~6500

Find a Location

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,224 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
847 Patients Enrolled for Diabetic Retinopathy
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,326 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,316 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
604 Patients Enrolled for Diabetic Retinopathy

Media Library

Fenofibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT04661358 — Phase 3
Diabetic Retinopathy Research Study Groups: Fenofibrate 160-mg, Placebo
Diabetic Retinopathy Clinical Trial 2023: Fenofibrate Highlights & Side Effects. Trial Name: NCT04661358 — Phase 3
Fenofibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04661358 — Phase 3
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT04661358 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Louisiana
Missouri
Other
How old are they?
65+
18 - 65
What site did they apply to?
Marietta Eye Clinic
Retina Research Institute, LLC
Thomas Eye Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

to see if i am border line diabetic and if so help to keep from getting. I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived 2+ prior treatments
I have tried multiple drugs, and nothing seems too work. I know with all this technology and new medicines something has to help. Please help! Thank you!
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
~344 spots leftby Apr 2029