ACTRN12611000249954
Recruiting
Phase 3
The Fenofibrate And Microvascular Events in Type 1 diabetes Eye: A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabete. A multicentre double-blind placebo-controlled study in Australia and internationally
HMRC Clinical Trials Centre, University of Sydney0 sites450 target enrollmentMarch 7, 2011
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Eye disease (retinopathy) in type 1 diabetes mellitus
- Sponsor
- HMRC Clinical Trials Centre, University of Sydney
- Enrollment
- 450
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligibility 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\-GAD, anti\-A2, anti\-ZnT8\).
- •2\) Age 18 years or over;
- •3\) 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;
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 3xULN;
Outcomes
Primary Outcomes
Not specified
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