A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation (FORTE Study)

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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. CONDITION: Diabetic Macular Oedema PRIMARY OUTCOME: Reduction in macular oedema, measured objectively as a decrease in central macular thickness (CMT) on Spectral Domain‐Optical Coherence Tomography (SD‐OCT). CMT in participants on fenofibrate will be compared to the CMT of participants on placebo. SECONDARY OUTCOME: Cost effectiveness of treatment of oral fenofibrate plus standard treatment versus standard treatment alone, assessed through linked MBS and PBS data. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score gains. Number of intravitreal anti‐VEGF injections or number of laser sessions needed for DME in each randomisation arm. If patients have received an anti‐VEGF injection or laser therapy at a particular visit, it is entered into the patient clinic file on that day. The number of injections or laser sessions will also be recorded at each of the mandated visits on clinical research forms (CRFs). INCLUSION CRITERIA: 1. Male or Female patients >= 25 years at the time of consent. 2. Diagnosed with type 2 diabetes 3. Diagnosed with DME on SD‐OCT.
Epistemonikos ID: bcb438d70e50a8e2eda930ed4e4439829e1983ea
First added on: Aug 24, 2024