Upper East Side Office

MaculaCare

Macular Edema

Retinal Diseases

Diabetic Retinopathy

Edema

Macular Degeneration

Tissue Adhesions

Retinal Perforations

Vitreous Hemorrhage

Hemorrhage

Geographic Atrophy

Bevacizumab

Fenofibrate

Squalamine Lactate

Ranibizumab

MSI-1256F

ranibizumab

dexamethasone

Pemafibrate

ORACEA®

Jaeb Center for Health Research

ThromboGenics

Genaera

Paul Yates, MD, PhD

condition

allSponsorName

Juvenile Diabetes Research Foundation (JDRF)

National Institutes of Health (NIH)

Roche

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

Fenofibrate for Prevention of DR Worsening

MaculaCare | Upper East Side Office

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Fenofibrate for Prevention of DR Worsening (Protocol AF)

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