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2023 OMIG Abstract

Characteristics of Pre-Screened Patients who did not Participate in the Zoster Eye Disease Study (ZEDS)

Ayodele K. Maja^1,5, Darren Gu¹, Lily Ge², Carlos Lopez-Jimenez³, Elisabeth J. Cohen⁴,
and Michael E. Zegans<sup>1.5

1</sup>Dartmouth Hitchcock Medical Center, Lebanon, NH; ²NYU Grossman School of Medicine (NYUGSoM),
New York, NY; ³Office of Science and Research, NYUGSoM, NYU Langone Health (NYULH), New York, NY; ⁴Department of Ophthalmology, NYUGSoM, NYULH, New York, NY; ⁵Geisel School of Medicine at Dartmouth, Hanover NH

Purpose: The Zoster Eye Disease Study (ZEDS) is a multicenter NEI-funded randomized clinical trial (RCT) to determine the efficacy of suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) that enrolled fewer than planned (527/780, 67.6%) participants. Understanding reasons for non-participation of likely eligible pre-screened patients provides insights into patient populations that are not represented by ZEDS and barriers in clinical trials.

Methods: HZO adults likely eligible for ZEDS with a history of a typical rash and a medical record within the past year of an episode of epithelial or stromal keratitis or iritis were pre-screened at activated Participating Clinical Centers (PCCs) from 2017 to 2022 using a standard prescreening log. De-identified data including demographic information, reasons for exclusion due to ineligibility, and patient refusal were retrospectively entered into REDCap and analyzed.

Results: Pre-screening logs with reasons for non-consent (1244/1706, 72.9%) were included in the data set. Patients were excluded from the study (915/1244, 73.6%) because they did not meet all inclusion criteria (619/915, 67.7%) or met an exclusion criterion (296/915, 32.3%). Among the twelve exclusion criteria for the ZEDS study, immunocompromise (76/296, 25.7%) and renal insufficiency (50/296, 16.9%) were most frequently reported. Patient refusal to participate (327/1244, 26.3%) was common.

Conclusions: The most common reasons for ineligibility were immunocompromise and renal insufficiency. There may be benefits to long-term antiviral use in these populations not captured in ZEDS. A quarter (26.3%) of pre-screened patients refused participation showing the substantial impact of patient preferences on trial participation.

Disclosure: S

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