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. Interest in objective measures derives from the subjective nature of clinical assessments and the imprecision of categorical data, which may result in failure to achieve study end-points in clinical trials. Objective measures are sought for each of the five signs of intraocular inflammation discussed at the March 2015 End-points Workshop, which are likely to be used in future clinical trials of uveitis. They are anterior chamber cells; vitreous inflammatory reactions, retinal vascular leakage, retinal infiltrates, and choroidal infiltrates. In addition, aqueous humor protein level (flare) may eventually be incorporated into studies of anterior uveitis.
Before objective measures can be used in clinical trials, a number of issues must be addressed, including appropriate devices for, and technical aspects of, data collection; how results will be quantified; interpretation of results; confounders; reliability and reproducibility of measurements; and validation against definitive outcome measures, such as retention of vision and lack of structural complications. These issues will be the focus of workshop discussions. In addition, representatives of the FDA will be invited to comment on regulatory issues relevant to use of devices and incorporation of objective measures into clinical trials.
Many isolated studies have been published or are in progress that look at the ability of devices to measure features of intraocular inflammation. This workshop will provide an opportunity to review these studies and propose additional studies with the overarching goal of standardization and incorporation into clinical trials. While other meetings have focused on one device or one particular technique, this workshop will discuss a variety of techniques with the primary focus of clinical trial design and end-points.
For more information, please contact firstname.lastname@example.org.