The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

Launched by UNIVERSITY OF SYDNEY · Mar 21, 2011

Keywords

ClinConnect Summary

The clinical trial titled "The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye" is looking to see if taking 145 mg of fenofibrate daily can help adults with type 1 diabetes who already have a mild form of eye damage known as non-proliferative diabetic retinopathy. This study is currently recruiting participants aged 18 and older, who have a specific eye condition confirmed by recent eye tests. To join the trial, individuals must have type 1 diabetes and meet certain health criteria, such as having healthy kidney function.

Participants in this study will be monitored closely and will need to attend regular clinic visits to check their health and the effects of the medication. It's important to note that some individuals, such as those with certain other eye conditions or those who have had specific eye treatments recently, may not be eligible to participate. Overall, this trial aims to explore a potential new treatment option for managing eye health in people living with type 1 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion criteria (for the main study):
• 1. Men or non-pregnant women (on acceptable contraception) with T1D\* according to standard criteria:
• • T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with: i) Documented history of ketoacidosis, and/or ii) Documented history of very low or undetectable C-peptide (fasting \<200 nmol/L or 0.2 pmol/L), and/or iii) Documented history of T1D related autoantibody/ies (anti-Glutamic acid decarboxylase, anti-A2, anti-ZnT8).
• • 2. Age 18 years or over;
• • 3. Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
• • 4. Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.;
• • 5. All types of insulin therapy, with no restriction by level of HbA1c;
• • 6. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
• • 7. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.
• • Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.
• Exclusion criteria:
• • 1. Definite indication for or contraindications to fibrate treatment (Other lipid drugs \[e.g. statins, ezetimibe, fish oils\] are allowed.);
• • 2. Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion);
• • 3. Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
• • 4. Prior bilateral intra-ocular injection(s) within the last 6 months;
• • 5. Bilateral cataract surgery within the last 6 months;
• • 6. Planned bilateral cataract surgery within the next 12 months;
• • 7. History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
• • 8. History of photosensitive skin rash or myositis;
• • 9. Abnormal thyroid function (untreated);
• • 10. Liver function tests exceeding 3x upper limit of normal (ULN);
• • 11. Persistent elevated unexplained blood creatinine phosphokinase level above normal range;
• • 12. Documented fasting triglycerides (TG) levels \>6.5 mmol/L;
• • 13. History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism;
• • 14. Use of investigational drugs in the prior 8 weeks;
• • 15. Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis;
• • 16. Myocardial infarction (MI), unstable angina, stroke or heart failure within last 6 months;
• • 17. Diagnosed cancer with ongoing treatment or prognosis anticipated at \<5 years;
• • 18. Any obstacle to regular follow-up including scheduled clinic attendances;
• • 19. Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.