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Evaluating fenofibrate for eye health in adults with type 1 diabetes

A Randomised Trial to Evaluate the Efficacy on Retinopathy and Safety of Fenofibrate in Adults With Type 1 Diabetes. A Multicentre Double-blind Placebo-controlled Study in Australia and Internationally.

Phase 3 Interventional University of Sydney · NCT01320345

This study is testing if taking fenofibrate daily can help protect the eyes of adults with type 1 diabetes who already have early signs of eye damage.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Sydney Academic / other
Locations24 sites (Garran, Australian Capital Territory and 23 other locations)
Trial IDNCT01320345 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of 145 mg of daily fenofibrate on adults with type 1 diabetes mellitus who have pre-existing non-proliferative diabetic retinopathy. Fenofibrate, a medication known for lowering blood fats, has previously shown promise in reducing eye damage in type 2 diabetes and in animal models of type 1 diabetes. The trial will involve 450 participants over an average duration of 36 months, comparing the effects of fenofibrate against a placebo. The primary focus is to determine if fenofibrate can prevent further eye damage in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with type 1 diabetes and non-proliferative diabetic retinopathy.

Not a fit: Patients who have undergone prior pan-retinal laser therapy or have an eGFR below 30 ml/min/1.73m2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of vision loss in patients with type 1 diabetes.

How similar studies have performed: Previous studies have shown fenofibrate to be effective in reducing eye damage in type 2 diabetes, suggesting potential for success in this type 1 diabetes population.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Garran, Australian Capital Territory and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 1 Diabetes MellitusDiabetic RetinopathyDiabetic NephropathiesDiabetes MellitusRetinopathyDiabetic NephropathyFenofibrate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.