drugset / Trial / NCT03439345
Lowering Events in Non-proliferative Retinopathy in Scotland
Phase 4
Completed
1151 enrolled
University of Oxford
NHS Scotland Diabetic Retinopathy Screening Collaborative · collabNational Institute for Health Research, United Kingdom · collabUniversity of Aberdeen · collabUniversity of Dundee · collabUniversity of Edinburgh · collabUniversity of Glasgow · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
LENS is a streamlined multicentre randomised placebo-controlled parallel-group trial investigating the effect of fenofibrate treatment on the progression of diabetic retinopathy/maculopathy.
Timeline
- Start
- 2018-07-23
- Primary completion
- 2023-11-17
- Completion
- 2024-02-16
Outcome
Met primary endpoint
registry analysis (superiority test); Fenofibrate 145 mg vs Placebo Oral Tablet; p = 0.006; Hazard Ratio (HR) 0.73 (95% CI 0.58 to 0.91); Regression, Cox NCT03439345 ↗
Publications
- Background LENS Collaborative Group. Design, recruitment and baseline characteristics of the LENS trial. Diabet Med. 2024 Sep;41(9):e15310. doi: 10.1111/dme.15310. Epub 2024 Feb 22.
- Results Preiss D, Logue J, Sammons E, Zayed M, Emberson J, Wade R, Wallendszus K, Stevens W, Cretney R, Harding S, Leese G, Currie G, Armitage J. Effect of Fenofibrate on Progression of Diabetic Retinopathy. NEJM Evid. 2024 Aug;3(8):EVIDoa2400179. doi: 10.1056/EVIDoa2400179. Epub 2024 Jun 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenofibrate | Small molecule | 145 mg | Oral |