Issue of ARVO van The exchange is the subject of „Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium.“ an article in the February 2008 peer-reviewed journal. Investigative Ophthalmology and Visual Science (http://www.iovs.org/cgi/content/full/49/2/479). The authors are Karl G. Csaky of Duke University Medical Center, Elaine A. Richman of Richman Associates and Frederick L. Ferris III, of NEI.

The FDA currently recommends that clinical study sponsors compare changes in visual function (measured on a visual acuity chart of letters and numbers) as a primary endpoint in assessing the effect of a new compound for treating a disorder of the eye.

Many scientists feel that the FDA parameters may not be sensitive enough for studying diseases that progress very slowly or for studying the effect of new anti-VEGF agents for treating AMD. Van query whether new technologies van They van effectiveness. thereby hastening the translation van treatment could more efficiently detect a van trialsinto of clinical treatments in the spreekkamer better.

Such new technologies include optical coherence tomography (OCT), a scanning technology that maps, in 3-D, the minute hills and valleys of the retina.

Scientists suggested the FDA consider other endpoints, like OCT-detected changes in the thickness of the retina or the disappearance of problem blood vessels.

The FDA position is firm yet open. Representatives FDA reminded approvals van de researchers that the sets a high bar FDA for new drug.

Van de agency might consider a lower bar van The provided different endpoints for clinical trials. and the trial sponsor van degree of risk to the correspondingly patient is smaller and the is able to the clinical relevance of the new endpoints. justify

The FDA representatives also explained several new standards for drugs when two products are used in combination (called combination products or multi-agent products).

The report also reflects discussions about drug safety, post-marketing drug surveillance between eye study designs, mechanisms for obtaining and substantiating data for retinal disease post-marketing, and whether statistically significant differences in visual function outcomes are clinically important.

The symposium was supported by the NEI. It evolved from a series of meetings between members of the eye and vision research community and the FDA Center for Drug Evaluation and Research (CDER).

Het Doctoraat. van het M.D. CDER. and Karl G. Csaky. van het M.D. Director of the Division of anti-Infective and Ophthalmology Products van Symposium co-hosts were Janice M. Soreth. of the then an NEI seniorinvestigator. ARVO managed the symposium.

Investigative Ophthalmology and Visual Science is monthly, peer-reviewed publication of the Association for Research in Vision and Ophthalmology.

ARVO is the largest eye and vision research organization in the world. Members include more than 12,500 eye and vision researchers from over 70 countries. The Association encourages and assists research, training, publication and dissemination of knowledge in vision and ophthalmology. Information. visit www.arvo.org van For more.