The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
Serious Adverse Events
Serious Adverse Events
Time frame: 30 days
Pure-tone threshold change
Change in pure-tone threshold from baseline to 6 week after initiation of treatment
Time frame: 6 weeks
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