CompletedPhase 4

Lowering Events in Non-proliferative Retinopathy in Scotland

United Kingdom1,151 participantsStarted 2018-07-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Capable of giving informed consent
✓. Diabetes Mellitus (any type except gestational diabetes)
✓. Observable diabetic retinopathy/maculopathy (defined based on NHS Scotland grading criteria as: R1 in both eyes or R2 in one/both eyes at the most recent retinal screening assessment; or M1 in one/both eyes at any retinal screening assessment in the 3 years)
✓. Willing to either complete electronic questionnaires or conduct telephone interviews for collection of data once every 6 months

Exclusion criteria

✕. Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
✕. History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
✕. History of acute or chronic pancreatitis
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2X the upper limit of normal (ULN) according to local NHS laboratory reference range at screening visit
✕. ALT or AST \>2.5X ULN according to local NHS laboratory reference range at randomisation visit
✕. Creatine kinase (CK) \>3X ULN according to local NHS laboratory reference range at screening visit
✕. CK \>3X ULN according to local NHS laboratory reference range at randomisation visit
✕. Estimated glomerular filtration rate (eGFR) \<40mL/min/1.73m2 at screening visit

What they're measuring

Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment

Timeframe: 4.0 years (interquartile range, 3.6 to 4.3) years

Trial details

NCT IDNCT03439345

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-17

Results submitted2024-11-11

View on ClinicalTrials.gov More Diabetic Retinopathy trials