Evidence map›Paper›PMID 38905569›Full record

Trial reportNEJM evidence2024

Effect of Fenofibrate on Progression of Diabetic Retinopathy.

David Preiss, Jennifer Logue, Emily Sammons, Mohammed Zayed, Jonathan Emberson, Rachel Wade, Karl Wallendszus, Will Stevens, Rosanna Cretney, Simon Harding and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in NEJM evidence, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03439345 (A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03439345 phase4completednot on this map

A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes

TypeinterventionalSponsorUniversity of OxfordRan2018 to 2024Enrolled1,151ConditionsDiabetic RetinopathyArmsFenofibrate 145 mg, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Fenofibrate in ophthalmology: therapeutic efficacy and mechanisms.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026
    Review
  13. Review
  14. Review
  15. Fibrates : Do They Still Have a Role in Therapy in 2025?Current atherosclerosis reports · 2025
    Review
  16. Review
  17. Article
  18. Article
  19. Repurposing medications to prevent psychosis.Npj mental health research · 2025
    Review
  20. Rapid Glycemic Correction and the Paradox of Retinopathy Progression.Endocrinology and metabolism (Seoul, Korea) · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

David PreissClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Jennifer LogueFaculty of Health and Medicine, University of Lancaster, Lancaster, United Kingdom.
Emily SammonsClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Mohammed ZayedClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Jonathan EmbersonClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Rachel WadeClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Karl WallendszusClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Will StevensClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Rosanna CretneyClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Simon HardingDepartment of Eye and Vision Science, University of Liverpool and St. Paul's Eye Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.
Graham LeeseMolecular and Clinical Medicine, University of Dundee, Dundee, United Kingdom.
Gemma CurrieSchool of Cardiovascular & Metabolic Health, University of Glasgow, Glasgow, United Kingdom.
Jane ArmitageClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.

Funding

Department of Health 14/49/84
6 · The paper itself

Abstract

backgroundFindings from cardiovascular outcome trials suggest that fenofibrate therapy may reduce the progression of diabetic retinopathy.

methodsWe recruited and followed adults with nonreferable diabetic retinopathy or maculopathy using the national Diabetic Eye Screening (DES) program in Scotland. We randomly assigned participants to receive 145-mg fenofibrate tablets or placebo (taken daily or, in those with impaired renal function, on alternate days). The primary outcome was a composite of developing referable diabetic retinopathy or maculopathy (based on Scotland's DES grading scheme) or treatment (intravitreal injection, retinal laser, vitrectomy) for retinopathy or maculopathy.

resultsA total of 1151 participants were randomly assigned to treatment. During a median of 4.0 years, progression to referable diabetic retinopathy or maculopathy, or treatment thereof, occurred in 131 (22.7%) of 576 participants in the fenofibrate group and 168 (29.2%) of 575 in the placebo group (hazard ratio, 0.73; 95% confidence interval [CI], 0.58 to 0.91; P=0.006). In the fenofibrate group compared with the placebo group, the frequencies for any progression of retinopathy or maculopathy were 185 (32.1%) vs. 231 (40.2%); hazard ratio, 0.74; 95% CI, 0.61 to 0.90 and for the development of macular edema were 22 (3.8%) vs. 43 (7.5%); hazard ratio, 0.50; 95% CI, 0.30 to 0.84. Seventeen (3.0%) participants assigned fenofibrate and 28 (4.9%) assigned placebo were given treatment for retinopathy (hazard ratio, 0.58; 95% CI, 0.31 to 1.06). There was no effect on visual function, quality of life, or visual acuity. Trial-averaged estimated glomerular filtration rate was 7.9 (95% CI, 6.8 to 9.1) ml/min/1.73 m

conclusionsFenofibrate reduced progression of diabetic retinopathy compared with placebo among participants with early retinal changes. (Funded by the National Institute for Health and Care Research; ClinicalTrials.gov number, NCT03439345; ISRCTN number, ISRCTN15073006.).

Indexed as

Diabetic RetinopathyDisease ProgressionFenofibrateHypolipidemic AgentsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedFenofibrateHypolipidemic Agents

Identifiers

PMID38905569
PMCPMC7616293

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.