Design, recruitment and baseline characteristics of the LENS trial
Authors' conclusion
LENS will provide a robust evaluation of the efficacy of treating people at risk of progression of diabetic retinopathy with fenofibrate. Results are anticipated in mid-2024.
Study context
- Population
- Adults with DM and non-referable retinopathy (mild background retinopathy in both eyes or observable background retinopathy in one/both eyes at most recent NHS retinal screening; or observable maculopathy in one/both eyes in previous 3 years), Scotlandrandomised
- Participants
- 1,151 adults
- Comparison
- Fenofibrate vs placebo
- Primary endpoint
- Progression to referable DR (referable background or proliferative retinopathy, or referable maculopathy in either eye) or treatment with retinal laser, intravitreal injections or vitrectomy
Methodological detailsstreamlined, double-masked, placebo-controlled, Scotland-based, routine healthcare data identification and record linkage follow-up, study treatment mailed, Recruitment 18 September 2018 to 27 July 2021
- Streamlined
- Double-masked
- Placebo-controlled
- Scotland-based
- Routine healthcare data identification and record linkage follow-up
- Study treatment mailed
- Recruitment 18 September 2018 to 27 July 2021
Primary result
As reported in the abstract
Baseline characteristics
- Mean age (SD 12), years
- 61
- Female
- 312 (27%)
- T1D
- 305 (26%)
- Bilateral mild background retinopathy
- 96%
- Observable maculopathy
- 10%
Original publication
Design, recruitment and baseline characteristics of the LENS trial. Diabet Med. Published 22 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →