The National Eye Institute (NEI) of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) will hold a symposium, titled “Ophthalmic Clinical Trial Design and Endpoints,” on November 28 - 29, 2006 in Washington, D.C. The purpose of the symposium is to discuss challenges to the development of therapies for age-related macular degeneration (AMD) and diabetic retinopathy, and to discuss if there are ways to expedite the process for bringing new treatments to people with these diseases.
“The goal of this symposium is to bring together experts in AMD and diabetic retinopathy to discuss the current procedural guidelines for clinical trials and address how these might best be updated to expedite the development and approval of therapies for these diseases,” explained Karl Csaky, MD, senior investigator in NEI’s Laboratory on Retinal Disease and Therapeutics and co-chair of the symposium. “This is important because more than four million people in the United States have diabetic retinopathy and an estimated 30 million people over the age of 60 will be affected by AMD by the year 2010,” Csaky continued. “It is crucial that we shorten the time it takes to get effective therapies to people who need them.”
The symposium will include a series of invited presentations by representatives of the NEI, FDA, and academia. It also will include a discussion of treatments for AMD and diabetic retinopathy, and procedures for evaluating the ongoing safety of new therapies after they have been marketed to the public.
Researchers and advocacy groups will be encouraged to attend. Observers will have the opportunity to submit questions and comments. Registration began September 15, 2006.