UCLA/AUS Workshop on Objective Measures of Intraocular Inflammation for Use in Clinical Trials
3/22/2019 7:00 am – 3/23/2019 5:00 pm
Stein Eye Institute
Los Angeles, CA
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This workshop is intended for ophthalmologists who participate in clinical research dealing with inflammatory eye diseases (uveitis specialists, retina specialists, pediatric ophthalmologists); clinical trialists; and pharmaceutical and device industry representatives.
The workshop is intended to be a follow-up meeting to the March 2015 NEI/FDA Workshop on Clinical Trial End-points for Inflammatory Eye Diseases, focusing specifically on one major issue raised in the first meeting: the goal of incorporating objective measures of inflammation into clinical trials, in lieu of subjective clinical measures. Examples include use of anterior chamber inflammatory cell density values derived from optical coherence tomography (OCT) devices and aqueous humor protein levels from laser flare photometry as replacements for clinically assigned categories of "cells" and "flare", based on slit lamp biomicroscopy. At the previous workshop, representatives of the FDA pointed out that there are issues of regulation and validation that must be addressed before such measures can be incorporated into clinical trials and accepted by the FDA.