A Novel Use of Area Under the Curve Analysis as an Outcome Measure in the Assessment of a Continuous Microdosing Fluocinolone Acetonide Implant (ILUVIENĀ®) – touchOPHTHALMOLOGY
LONDON, May 4, 2017 /PRNewswire/ —
Sepehr Bahadorani, Michael A Singer, US Ophthalmic Review, 2017;10(1):46-51 DOI: https://doi.org/10.17925/USOR.2017.10.01.46
Published recently in US Ophthalmic Review, the peer-reviewed journal from touchOPHTHALMOLOGY, Sepehr Bahadorani and Michael A Singer discuss the treatment of diabetic macular edema (DME) and assert that it has become one of the most challenging management issues faced by ophthalmologists in daily practice. This, they argue, is partly due to the multifactorial nature of DME, progression of the disease and the clinical capacity needed to administer intravitreal injections. They also comment that 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, they stress that 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. Of particular interest in this article is Bahadorani and Singer’s description of an approach to data analysis using an area under the curve (AUC) method which is an ideal tool for assessing sustained release therapies such as dexamethasone (OzurdexĀ®, Allergan Inc., California, US) and intravitreal fluocinolone acetonide implant (0.2Ī¼g/day FAc implant; IluvienĀ®, 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 0.2Ī¼g/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 by readers for their own applications.
The full peer-reviewed, open-access article is available here:
https://doi.org/10.17925/USOR.2017.10.01.46
Disclosure:Ā Sepehr Bahadorani has nothing to declare in relation to this article. Michael Singer would like to disclose consultant speaker research for Allergan, consultant speaker research for Genentech, speaker research for Regeneron and consultant research for Alimera Sciences.
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