LENS
Trial question
What is the effect of fenofibrate in patients with diabetes mellitus and non-referable diabetic retinopathy or maculopathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 1151
1151 patients (312 female, 839 male).
Inclusion criteria: adults with diabetes mellitus and non-referable diabetic retinopathy or maculopathy.
Key exclusion criteria: clinically significant diabetic retinopathy; history of gallbladder disease; acute or chronic pancreatitis; eGFR < 30 mL/min/1.73 m²; cirrhosis or any other serious hepatic disease; RRT.
Interventions
N=576 fenofibrate (at an oral dose of 145 mg/day).
N=575 placebo (matching placebo).
Primary outcome
Progression to referable diabetic retinopathy or maculopathy or treatment for retinopathy or maculopathy
22.7%
29.2%
29.2 %
21.9 %
14.6 %
7.3 %
0.0 %
Fenofibrate
Placebo
Significant
decrease ▼
NNT = 15
Significant decrease in progression to referable diabetic retinopathy or maculopathy or treatment for retinopathy or maculopathy (22.7% vs. 29.2%; HR 0.73, 95% CI 0.58 to 0.91).
Secondary outcomes
Significant decrease in any progression of retinopathy or maculopathy (32.1% vs. 40.2%; HR 0.74, 95% CI 0.61 to 0.9).
Significant decrease in development of macular edema (3.8% vs. 7.5%; HR 0.5, 95% CI 0.3 to 0.84).
No significant difference in treatment for diabetic retinopathy or maculopathy (3% vs. 4.9%; HR 0.58, 95% CI 0.31 to 1.06).
Safety outcomes
No significant difference in serious adverse events and death.
Conclusion
In adults with diabetes mellitus and non-referable diabetic retinopathy or maculopathy, fenofibrate was superior to placebo with respect to progression to referable diabetic retinopathy or maculopathy or treatment for retinopathy or maculopathy.
Reference
David Preiss, Jennifer Logue, Emily Sammons et al. Effect of Fenofibrate on Progression of Diabetic Retinopathy. NEJM Evid. 2024 Aug;3(8):EVIDoa2400179.
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