ISRCTN15073006已完成4 期
A randomised placebo-controlled trial of fenofibrate to prevent progression of non-proliferative retinopathy in diabetes
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,151
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38385587/ baseline characteristics (added 23/02/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38905569/ primary outcome results (added 25/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Capable of giving informed consent
- •2. Diabetes Mellitus (any type except gestational diabetes)
- •3. Observable diabetic retinopathy/maculopathy
- •(defined based on NHS Scotland retinal screening 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 last 3 years)
- •4. Willing to either complete electronic questionnaires or conduct telephone interviews for collection of data once every 6 months
排除标准
- •Current exclusion criteria as of 16/03/2021:
- •1. Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
- •2. History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
- •3. History of acute or chronic pancreatitis
- •4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X the upper limit of normal (ULN) according to local NHS laboratory reference range at screening visit
- •5. ALT or AST >2.5X ULN according to local NHS laboratory reference range at randomisation visit
- •6. Creatine kinase (CK) >3X ULN according to local NHS laboratory reference range at screening visit
- •7. CK >3X ULN according to local NHS laboratory reference range at randomisation visit
- •8. Estimated glomerular filtration rate (eGFR) <40mL/min/1.73m2 at screening visit
- •9. eGFR <30mL/min/1.73m2 at randomisation visit
- •10. Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
- •11. Female who is pregnant, breastfeeding, currently trying to become pregnant, or of childbearing potential and not practising birth control
- •12. Ongoing vitamin K antagonist (warfarin, phenindione, acenocoumarol), cyclosporine, colchicine, ketoprofen, daptomycin, fibrate therapy, or treatment with rosuvastatin 40mg daily
- •13. Previous myositis, myopathy or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder
- •14. Ongoing renal replacement therapy
- •15. Any previous organ transplant
- •16. Previous reported intolerance to any fibrate
- •17. Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer within last 5 years other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
- •18. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •19. LENS participants can participate in other research studies, including clinical trials. The only exclusions related to co-enrolment will be: if any other study or trial excludes co-enrolment or if the intervention being investigated in another trial has the potential to interact with fenofibrate therapy.
- •20. Not adherent to active run-in treatment
- •Previous participant exclusion criteria as of 18/10/2019:
- •1. Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
- •2. History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
- •3. History of acute or chronic pancreatitis
- •4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X the upper limit of normal (ULN) according to local NHS laboratory reference range at screening visit
- •5. ALT or AST >2.5X ULN according to local NHS laboratory reference range at randomisation visit
- •6. Creatine kinase (CK) >3X ULN according to local NHS laboratory reference range at screening visit
- •7. CK >3X ULN according to local NHS laboratory reference range at randomisation visit
- •8. Estimated glomerular filtration rate (eGFR) <40mL/min/1.73m2 at screening visit
- •9. eGFR <30mL/min/1.73m2 at randomisation visit
- •10. Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
- •11. Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child-bearing potential and not practising birth control
研究者
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