Intratympanic Injection for Autoimmune Inner Ear Disease

Safety and Efficacy of Intratympanically Delivered Golimumab for Stabilization of Hearing in Patients With Autoimmune Inner Ear Disease: An Open-label Proof-of-concept Clinical Trial

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526174

Acronym

AIED

Enrollment

Registered

2012-02-03

Start date

2012-03-31

Completion date

2014-04-30

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Inner Ear Disease

Keywords

autoimmune, hearing loss, bilateral hearing loss, steroid-dependent

Brief summary

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.

Interventions

DRUGGolimumab

Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator * Idiopathic, bilateral sensorineural hearing loss * History of, or audiograms showing, rapid progression of hearing loss * Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz) * Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection. * Provided written informed consent for participation in the clinical study

Exclusion criteria

* Positive MRI for vestibular schwannoma * Positive FTA (syphilis) * Significant middle ear disease (e.g., otitis media) * Positive blood test for Lyme disease * Positive tuberculosis test * Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides \[e.g., gentamicin\], cisplatin, loop diuretics, Yorgason et al., 2006) * Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators * Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu) * Positive test for HIV * Positive test for Hepatitis B and C * Presence of a demyelinating disease, such as multiple sclerosis * Women of childbearing potential only: Positive serum pregnancy test prior to the only/first injection * Active infections

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events	30 days	Serious Adverse Events
Pure-tone threshold change	6 weeks	Change in pure-tone threshold from baseline to 6 week after initiation of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026