The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye. (NCT01320345) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
Australia412 participantsStarted 2016-11-03
Plain-language summary
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or non-pregnant women (on acceptable contraception) with T1D\* according to standard criteria:
✓. Age 18 years or over;
✓. Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
✓. 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.;
✓. All types of insulin therapy, with no restriction by level of HbA1c;
✓. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
✓. 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.
Exclusion criteria
✕. Definite indication for or contraindications to fibrate treatment (Other lipid drugs \[e.g. statins, ezetimibe, fish oils\] are allowed.);
✕. 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);
✕
What they're measuring
1
Occurrence of clinical significant retinopathy progression.
Timeframe: As reported throughout the study and/or annual eye assessment post-randomisation