The Value of Area Under the Curve Analysis as an Outcome Measure in the Assessment of a Continuous Microdosing Fluocinolone Acetonide Implant (ILUVIEN

Abstract

T he treatment of diabetic macular edema (DME) has become one of the most challenging management issues faced by ophthalmologists in daily practice. This is partly due to the multifactorial nature of DME, progression of the disease and the clinical capacity needed to administer intravitreal injections. In recent years, the treatment options for DME have expanded to include intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents and steroids, and most recently, the use of intravitreal implants. In determining clinically relevant endpoints for clinical studies of these treatments, it is important to consider the patient’s journey and experience with a treatment over a specific time-period rather than isolated outcomes at a pre-specified time-point. Area under the curve (AUC) is an ideal tool for data analysis particularly when it comes to sustained release therapies such as dexamethasone (Ozurdex®, Allergan Inc., California, US) and intravitreal fluocinolone acetonide implant (0.2μg/day FAc implant; Iluvien®, Alimera Sciences Inc., Georgia, US). Unlike single time-point outcomes, AUC analysis provides the average letters gained per day over the entire treatment period, providing a better measure of long-term effectiveness. A recent analysis using the AUC approach highlights the significant visual acuity benefit resulting from the 0.2μg/day fluocinolone acetonide (FAc) implant during the FAME (Fluocinolone Acetonide for Macular Edema) trials. A step-by-step instruction is included in this article that allows statistical analysis of the AUC data from both functional and anatomical outcomes, using a free software tool to further facilitate the use of this technique for future investigators.