Effect of fenofibrate on diabetic retinopathy progression: an RCT-Only systematic review and meta-analysis incorporating the LENS trial

Diabetes Res Clin PractPublished Systematic review and meta-analysis of randomised trials

Authors' conclusion

In adults with diabetes, predominantly type 2, fenofibrate slows structural DR progression but is not established as vision-preserving.

Study context

Population
Adults with diabetes, predominantly T2D (one trial 26% T1D), in randomised trials of fenofibrate reporting an ophthalmic outcome
Participants
3,756 adults3 trials
Comparison
Fenofibrate vs control
Outcome
DR progression
Methodological detailspre-registered PRISMA 2020 protocol, random-effects, RoB 2, GRADE, Four databases searched to June 25, 2026; 10 studies included (6 completed with extractable results, 4 ongoing)
  • Pre-registered PRISMA 2020 protocol
  • Random-effects
  • RoB 2
  • GRADE
  • Four databases searched to June 25, 2026; 10 studies included (6 completed with extractable results, 4 ongoing)

Pooled result

As reported in the abstract

Pooled RR for diabetic retinopathy (DR) progression (3 trials, N = 3,756)

RR 0.77

95% CI 0.68–0.88

HKSJ interval

0.60-0.99

Heterogeneity

I2 0%

Absolute effect

45 fewer events per 1,000

Further pooled results

DR progression, LENS composite definition

Stratified RR
0.80 (0.68-0.93)
  • Difference between strata P = 0.37

DR progression, ETDRS step-based definitions

Stratified RR
0.70 (0.55-0.90)
  • Difference between strata P = 0.37

Need for retinal treatment

RR, conventional model
RR 0.68, 0.57-0.82
HKSJ interval crossed the null
0.42-1.11
Weight from one pre-anti-VEGF-era trial
90.2%
  • Low certainty
  • Not firm evidence about contemporary treatment need

Visual acuity or function

No trial found benefit for visual acuity or function
  • Low certainty

Macular edema

Macular edema evidence was not combinable
  • Very low certainty

Safety

VTE increased
RR 1.52, 1.12-2.06
Events (FIELD only)
103/4,755 vs 68/4,767
  • Estimate derived entirely from FIELD

Original publication

Effect of fenofibrate on diabetic retinopathy progression: an RCT-Only systematic review and meta-analysis incorporating the LENS trial. Diabetes Res Clin Pract. Published 4 September 2026. doi:10.1016/j.diabres.2026.113543

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