This Small Business Innovation Research project aims to develop an innovative eye drop formulation for the treatment of diabetic retinopathy. The goal of this proposal is to develop substantial efficacy, safety, and pharmacokinetic data to support the clinical development of topical fenofibrate. We hypothesize that topical application of fenofibrate can reduce vision loss and neovascularization in animal models of diabetes and retinal disease. The goal of this proposal is to 1) evaluate the efficacy of topical fenofibrate on preventing visual acuity loss in a rat model of streptozotocin-induced diabetes We will give fenofibrate eye drops either two or four times a day for 16 weeks. We will measure the change of visual acuity over this time period. The long term goal (Phase 2) is to perform safety studies and find a commercial manufacturer for the formulation.
Nearly all patients with type 1 diabetes, and >60% of type 2 diabetic patients will develop some form of retinopathy and visual loss in their lifetime. Fenofibrate is a peroxisome proliferator-activated receptor alpha (PPAR?) agonist that has been shown in both The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trials to reduce the progression of diabetic retinopathy in diabetic patients. Oral fenofibrate appears to have limited systemic benefit in diabetic patients, thus the topical application of fenofibrate for diabetic eye disease represents a more targeted and safe approach to treat diabetic retinopathy.
