RecruitingACTRN12618000592246

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


Sponsor

University of Sydney

Enrollment

392 participants

Start Date

Sep 12, 2018

Study Type

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

Sex: Both males and femalesMin Age: 25 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing whether fenofibrate — an oral cholesterol-lowering tablet that has shown promise in slowing diabetic eye disease — can reduce swelling at the back of the eye (diabetic macular oedema) in people with Type 2 diabetes. Diabetic macular oedema is a leading cause of vision loss in people with diabetes, and current treatments involve injections into the eye or laser therapy, which carry risks, costs, and discomfort. Participants will be randomly assigned to take a daily fenofibrate tablet or a placebo alongside their existing eye care for the duration of the study. The main question is whether fenofibrate reduces the swelling and lessens the need for invasive eye injections or laser procedures. You may be eligible if you are 25 or older, have Type 2 diabetes, and have been diagnosed with diabetic macular oedema on an OCT scan. People who are already taking fenofibrate, are pregnant or planning pregnancy, have other causes of macular swelling, or have had previous treatment for diabetic macular oedema in the last 12 months are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

NSW, Australia

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