Clinical Endpoints for Back of the Eye Diseases

Abstract

The development of new drugs and drug delivery devices for the treatmentof posterior eye diseases is critically dependent on the potential forthat drug to be approved by the United States Food and DrugAdministration (FDA). This approval process is predicated on thesuccessful achievement of endpoints in large multicenter clinicaltrials. This chapter will discuss the history and evolving nature ofendpoints for these clinical trials. Updates on recent novel endpointswill be discussed as well as the potential for the use of readouts fromvarious imaging tools of the retina as FDA acceptable endpoints forclinical trials.