Effect of fenofibrate on diabetic retinopathy progression: an RCT-Only systematic review and meta-analysis incorporating the LENS trial.
Manish Bhandari, Sandesh Devkota, Rubina Dhital et al.
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In 30 seconds
This pre-registered systematic review and meta-analysis included randomized trials of fenofibrate reporting eye outcomes in adults with diabetes, predominantly type 2. Ten studies met inclusion criteria; six were completed and four ongoing, while three completed trials contributed to the primary analysis. Fenofibrate was associated with less diabetic retinopathy progression than control (3 trials; N = 3,756; RR 0.77, 95% CI 0.68-0.88; moderate certainty), equivalent to 45 fewer events per 1,000. The review found no established benefit for visual acuity or function, so reduced structural progression should not be interpreted as proven vision preservation.
Key findings
- Across three trials (N = 3,756), fenofibrate reduced diabetic retinopathy progression: RR 0.77 (95% CI 0.68-0.88; moderate certainty), or 45 fewer events per 1,000.
- No trial found benefit for visual acuity or function; evidence for these outcomes was low certainty.
- Retinal treatment need was lower under the conventional model (RR 0.68, 0.57-0.82), but the HKSJ interval crossed the null (0.42-1.11) and certainty was low.
- Venous thromboembolism was increased (RR 1.52, 1.12-2.06), based entirely on FIELD.
Why it matters
The findings distinguish slowing of retinal structural progression from preservation of vision, an outcome patients and clinicians ultimately value. They support considering fenofibrate’s retinal effects as a potential benefit in adults with diabetes, while the absence of demonstrated visual-function benefit and the venous thromboembolism signal underscore the need to weigh outcomes and uncertainty rather than infer a broad ophthalmic benefit.
What to keep in mind
Only three completed trials contributed to the primary pooled outcome, and participants were predominantly people with type 2 diabetes. Visual acuity and function evidence was low certainty; macular edema evidence could not be combined.