Journal Article Discusses New AMD Treatments

An article, titled "Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium," has been published in the February 2008 issue of the Association for Research in Vision and Ophthalmology's peer-reviewed journal Investigative Ophthalmology and Visual Science, the direct result of a roundtable discussion with FDA representatives on Nov. 28-29, 2006.

At this meeting, discussion focused on endpoints and clinical trial strategies for evaluating new treatments for age-related macular degeneration (AMD), diabetic retinopathy, and other severe retinal disorders.

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.

ARVO reports that 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. They query whether new technologies could more efficiently detect a treatment's effectiveness, thereby hastening the translation of clinical trials into better treatments in the doctor's office.

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

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.

For more information, visit www.arvo.org.

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