The objective of this study was to evaluate the effect of several ophthalmologic
prophylactic treatment strategies for the management of ocular side effects (OSEs) in
participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM)
who were being treated with depatuxizumab mafodotin (ABT-414).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03419403.
This Phase 3b open-label, randomized, exploratory study included 2 phases during the
treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and
adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both
phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments
(standard steroids; standard steroids with vasoconstrictors and cold compress; and
enhanced steroids with vasoconstrictors and cold compress. The study comprised a
screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation
Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of
chemoradiation, and a Follow-Up Phase.
