Fenofibrate for Prevention of DR Worsening

Summary

This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.

In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.

Conditions

• Diabetic Retinopathy

Interventions

DRUG

Fenofibrate

Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.

OTHER

Placebo

Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Eye Institute (NEI)

  collaborator NIH

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Roche Pharma AG

  collaborator INDUSTRY

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Emily Y Chew, MD · National Institutes of Health (NIH)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-05

Primary Completion

2029-12-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations