A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation (FORTE Study)
A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation
University of Sydney
392 participants
Sep 12, 2018
Interventional
Conditions
Summary
This study is aimed at patients with Type 2 diabetes diagnosed with fluid retention in the back of the eye called "diabetic macular oedema" (DME), a main cause of vision impairment in diabetic eye disease. Standard treatments include anti-vascular endothelial growth factor injections or laser therapy to the affected eye. These are invasive, costly and carry significant risks including risk of blindness. This study will investigate whether fenofibrate (an oral agent shown to slow progression of diabetic retinopathy) reduces DME and thereby reduce the standard treatment interventions required. Cost-effectiveness for standard treatment versus standard treatment with fenofibrate will be compared.
Eligibility
Inclusion Criteria3
- Male or Female patients >= 25 years at the time of consent.
- Diagnosed with type 2 diabetes
- Diagnosed with DME on SD-OCT.
Exclusion Criteria6
- Current use of fenofibrate
- Pregnancy, or intention to become pregnant within the trial period
- Contraindication to fenofibrate use.
- Other causes of macular oedema including epiretinal membrane, vitreomacular traction, retinal vein occlusion, AMD, cataract surgery in the last 6 months.
- Previous treatment for DME in the prior 12 months including focal/grid laser, anti-VEGF injections, intravitreal triamcinolone injections.
- Active retinal neovascularisation requiring pan retinal photocoagulation laser therapy.
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Interventions
Participants in the intervention arm will be asked to take one tablet of 145mg fenofibrate, once daily for 2 years. Adherence to the study drug will be monitored by drug tablet return, where the study coordinator will count the number of tablets in the bottle at the mandated study visits. Participants will be reviewed at pre-specified intervals within the 2 years of the study, and anti-VEGF (ranibizumab 0.5mg or aflibercept 2mg) or laser treatment administered in participants with clinical diabetic macular oedema (DME), according to an established protocol. Anti-VEGF injections or laser treatment are the 'standard care' for patients with clinical DME. 'Standard care' for pre-clinical DME is observation. Pre-clinical DME will be observed and only be treated if it progresses to clinical DME.
Locations(1)
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ACTRN12618000592246