Fenofibrate 160mg for Diabetic Retinopathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetic Retinopathy+1 More
Fenofibrate 160mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 4 years

4 years
Development of CI-DME
Development of CI-DME in either eye
Development of center-involved diabetic macular edema with vision loss
Eye
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema in either eye including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
Visual acuity loss from any cause
4- years
Diabetic Retinopathy

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Fenofibrate 160-mg
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

910 Total Participants · 2 Treatment Groups

Primary Treatment: Fenofibrate 160mg · Has Placebo Group · Phase 3

Fenofibrate 160-mgExperimental Group · 2 Interventions: Fenofibrate 160mg, Fenofibrate · Intervention Types: Drug, Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate
2018
Completed Phase 4
~6500

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Roche Pharma AGIndustry Sponsor
377 Previous Clinical Trials
357,695 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
46 Previous Clinical Trials
62,310 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,416 Previous Clinical Trials
24,556,557 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
604 Patients Enrolled for Diabetic Retinopathy
Jaeb Center for Health ResearchLead Sponsor
139 Previous Clinical Trials
30,783 Total Patients Enrolled
11 Trials studying Diabetic Retinopathy
4,417 Patients Enrolled for Diabetic Retinopathy
Juvenile Diabetes Research FoundationOTHER
201 Previous Clinical Trials
54,632 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
847 Patients Enrolled for Diabetic Retinopathy
National Eye Institute (NEI)NIH
515 Previous Clinical Trials
1,072,026 Total Patients Enrolled
45 Trials studying Diabetic Retinopathy
38,618 Patients Enrolled for Diabetic Retinopathy
Emily Y Chew, MDStudy ChairNational Institutes of Health (NIH)
2 Previous Clinical Trials
4,255 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have only one eye with microaneurysms (DR severity level 20).
You have type 1 or type 2 diabetes.
The best-corrected visual acuity letter score of 79 or better.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri50.0%
New Mexico25.0%
Texas25.0%
How old are they?
18 - 6566.7%
65+33.3%
What site did they apply to?
Retina Research Institute, LLC50.0%
The Curators of the University of Missouri50.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%

How responsive is this trial?

Typically responds via
Email100.0%