For Prospective Zoster Eye Disease Study Participants
Study participants are a vital part of NYU Langone’s Zoster Eye Disease Study (ZEDS). By participating in our study, you enable us to find the best treatment for shingles of the eye, also known as herpes zoster ophthalmicus (HZO).
Clinical studies can determine, in strict, scientifically controlled settings, what the best treatment is for many medical conditions. Every effort is made to ensure that participation in studies is safe.
We encourage people from different backgrounds to enroll in our study. Our consent form to participate is also available in Spanish and can be given to you in person or mailed or emailed to you.
Zoster Eye Disease Study Objectives and Participation Criteria
The purpose of our study is to determine whether a low dose of the antiviral medication valacyclovir taken by mouth for one year is effective in reducing complications of HZO. We are enrolling study participants age 18 years and older with working immune systems who have received a diagnosis of HZO associated with a typical rash anytime in the past; with an episode of active keratitis, which is infection or inflammation of the cornea; or with iritis, which is inflammation inside the front part of the eye, within 1 year before enrollment.
Benefits of Participating in Our Zoster Eye Disease Study
If you have HZO and are already considering treatment with antiviral medications, you should know that no high-quality studies performed so far have determined whether antiviral medications work to decrease complications of HZO. The best way to find this out is by randomly assigning study participants to take either an active antiviral medication or a placebo that looks identical.
Participation in our study is especially safe because valacyclovir, the active study medication, was approved by the U.S. Food and Drug Administration (FDA) more than 20 years ago. The FDA approval of valacyclovir includes long-term use of a low dose to treat infection with another virus related to the shingles virus.
Furthermore, if you develop new or worsening eye disease during the course of the study, the doctor seeing you can stop the study medication temporarily or permanently and begin antiviral medication for a short or extended time, if the doctor thinks it will help in treating the eye disease. You will continue to receive close follow-up care during the study.
Zoster Eye Disease Study Visits
There are eight study visits, some of which may coincide with when you would need to be seen to check your eye if you were not in the study. At the first visit, we obtain informed consent from you, and blood tests are ordered to make sure you are eligible. At the next visit, study medication is given to you. There are then follow-up visits every 3 months for a period of 18 months. Every effort will be made to ensure that study visits are scheduled at times that are convenient for you, and that you will not have to wait when you arrive. The visits have to be completed within a specific time frame, but there is some flexibility in the timing of the individual visits, so they can be as convenient for you as possible.
Dose of Zoster Eye Disease Study Medication
The dose of active study medication used in our study is much lower than the dose used for actual treatment of the condition. Unlike some formulations of valacyclovir, the study medication does not contain lactose, which can upset one’s stomach. If you experience side effects, the dose can be adjusted and reduced.
If you find the study medication capsule difficult to swallow, you can mix it with applesauce or yogurt. You may not cut or crush the capsule.
You can get vaccinated against shingles before or during the study. The Shingrix vaccination is approved for adults age 50 years and older and for immunocompromised adults age 18 and older; this includes people with a history of shingles, in order to prevent another episode in a different location. The timing of vaccination for people with HZO is not specified, although it is usually delayed until the eye disease is well controlled.
Eye Doctor Visits
You can continue to see your local eye doctor between study visits and have them send a copy of the record of the visit to the study doctor. You will need to see the study doctor, however, if you develop new or worsening HZO.
If you would like to speak with us for more information, including how to participate in this important study, please contact Christina R. Prescott MD, PhD, principal investigator, at firstname.lastname@example.org, or Tonya Robin, study coordinator, at email@example.com. You can also contact the ZEDS Coordinating Center at 1-844-698-ZEDS (1-844-698-9337) or firstname.lastname@example.org.