NYU Langone Medical Center will lead a 5-year, 60-center clinical trial to evaluate new treatment protocols for herpes zoster ophthalmicus (HZO), a form of shingles that can seriously and permanently affect the eye. The project is being funded through a $15 million grant from the National Eye Institute, a division of the National Institutes of Health.
Entitled the Zoster Eye Disease Study (ZEDS), it will investigate the longer-term use of suppressive antiviral medication to reduce complications of HZO, which can lead to loss of vision, itching above the eye, chronic pain, and even stroke.
Elisabeth J. Cohen, MD, professor of ophthalmology at NYU Langone who will serve as principal investigator on the study, has focused her research primarily on this disease after suffering from it herself in 2008, resulting in a permanent impairment of her vision. In addition to creating and advocating for ZEDS, she has worked on national efforts to promote the vaccine to prevent shingles.
“There is no greater champion for this initiative than Dr. Elisabeth Cohen,” says Joel S. Schuman, MD, professor in the departments of Ophthalmology and Neuroscience and Physiology and chair of the Department of Ophthalmology at NYU Langone. “She and the other clinical researchers and clinicians on this study have enormous opportunity to improve the health of millions of people worldwide suffering from herpes zoster.”
There are an estimated 1 million cases of shingles (herpes zoster) each year in the United States alone, with HZO accounting for as many as 20 percent of all herpes zoster cases. The current standard treatment involves short-term use of a high dose of the antiviral valacyclovir. The trial will test the efficacy of administering a lower dose of the medication over the course of an entire year. The trial will enroll 1,050 patients, randomly assigned to receive either the masked active ingredient or a placebo.
“We already know that longer-term suppressive treatment has greatly improved outcomes for herpes simplex eye disease, which shares key similarities to herpes zoster eye disease,” says Dr. Cohen. “Our goal is to help patients preserve their vision and reduce the chronic pain that is so often one of the complications of the disease in older persons.”
In addition to Dr. Cohen, Judith D. Goldberg, ScD, a professor in the Department of Population Health’s Division of Biostatistics, and Judith S. Hochman, MD, the Harold Snyder Family Professor of Cardiology in the Department of Medicine, associate director of the Leon H. Charney Division of Cardiology, and the Senior Associate Dean for Clinical Sciences at NYU Langone, will serve as the trial’s principal investigators.