Imaging endpoints in clinical trials

Summary Clinical drug trials usually rely on primary endpoints that are well‐described direct measures of patient benefit or are closely related to clinical outcomes such as visual field testing. However, there is a lack of short‐term, easy to measure, highly reproducible endpoints predictive for visual acuity outcomes that would qualify as sufficiently predictive variables for patients′ benefit in clinical trials. This of special importance for the follow up of slowly developing diseases, which requires long‐term studies with large sample sizes. The rapid progression in the development of in‐vivo imaging techniques offers now new and exiting possibilities to assess human anatomic or physiologic information in unprecedented high resolution. Thus, the use of these new imaging techniques such as optical coherence tomography as possible endpoints in clinical phase III trials has been widely and controversially discussed. This talk aims to summarize the potential and limitations of modern imaging techniques to serve as surrogate parameters to substitute for clinical endpoints in ocular drug development.