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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.
Must not have
Participant-level exclusion criterion: Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2
Eye-level exclusion criteria: History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is normal or only mildly reduced, not requiring dialysis.
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I haven't had eye injections for any condition in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diabetic Retinopathy
Secondary study objectives
Development of CI-DME
Development of center-involved diabetic macular edema with vision loss
Visual acuity loss from any cause

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
K-877 and Fenofibrate Placebo: 40-Week Extension
K-877: 12-Week Efficacy
Placebo: 12-Week Efficacy
Fenofibrate and K-877 Placebo: 40-Week Extension

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
235 Previous Clinical Trials
141,793 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
847 Patients Enrolled for Diabetic Retinopathy
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
66 Previous Clinical Trials
99,135 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,837 Previous Clinical Trials
8,171,146 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
604 Patients Enrolled for Diabetic Retinopathy
Roche Pharma AGIndustry Sponsor
411 Previous Clinical Trials
410,950 Total Patients Enrolled
National Eye Institute (NEI)NIH
558 Previous Clinical Trials
1,407,911 Total Patients Enrolled
50 Trials studying Diabetic Retinopathy
42,285 Patients Enrolled for Diabetic Retinopathy
Jaeb Center for Health ResearchLead Sponsor
158 Previous Clinical Trials
35,029 Total Patients Enrolled
11 Trials studying Diabetic Retinopathy
4,417 Patients Enrolled for Diabetic Retinopathy
Emily Y Chew, MDStudy ChairNational Institutes of Health (NIH)
2 Previous Clinical Trials
4,255 Total Patients Enrolled

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
~297 spots leftby Apr 2029
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