Intracochlear Injection of Glucocorticoid

NCT07134075 | Not Yet Recruiting Phase 2

• 2 other identifiers: intracochlear glucocorticoid82225014
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.

Conditions

Sudden Sensorineural Hearing Loss (SSNHL)

Keywords

intracochlear injection; glucocorticoid

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in pure tone audiometry (PTA)

  hearing capacity of thresholds (PTA)

  Baseline, Week 2, Week 4, Week12, Week24

• Change from Baseline in auditory brainstem response (ABR)

  hearing capacity of thresholds (ABR)

  Baseline, Week 2, Week 4, Week12, Week24

• Change from Baseline in auditory steady state response (ASSR)

  hearing capacity of thresholds (ASSR)

  Baseline, Week 2, Week 4, Week12, Week24

• Change from Baseline in speech Discrimination Scores

  hearing capacity of thresholds (speech Discrimination Scores)

  Baseline, Week 2, Week 4, Week12, Week24

Secondary Outcomes (3)

• change from baseline in tinnitus handicap inventory

  Baseline, Week2, Week4, Week12, Week24

• change from baseline in dizziness handicap inventory

  Baseline, Week2, Week4, Week12, Week24

• change from baseline in quality of life score

  Baseline, Week2, Week4, Week12, Week24

Study Arms (4)

Group A: intracochlear triamcinolone acetonide injection

EXPERIMENTAL

intracochlear injection of triamcinolone acetonide through the round window membrane

Drug: intracochlear triamcinolone acetonide injection

Group B: intracochlear dexamethasone injection

EXPERIMENTAL

intracochlear injection of dexamethasone through the round window membrane

Drug: intracochlear injection of dexamethasone through the round window membrane

Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection

EXPERIMENTAL

intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane

Drug: intracochlear dexamethasone injection and intratympanic dexamethasone injection

Group D: intratympanic dexamethasone injection

ACTIVE COMPARATOR

intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections.

Drug: intratympanic dexamethasone injection

Interventions

intracochlear triamcinolone acetonide injection DRUG

intracochlear triamcinolone acetonide injection of through the round window membrane

Also known as: intracochlear triamcinolone acetonide （40mg/ml, 30μl）injection

Group A: intracochlear triamcinolone acetonide injection

intracochlear injection of dexamethasone through the round window membrane DRUG

intracochlear injection of dexamethasone sodium phosphate through the round window membrane

Also known as: intracochlear injection of dexamethasone sodium phosphate（7.5mg/ml, 30μl）through the round window membrane

Group B: intracochlear dexamethasone injection

intracochlear dexamethasone injection and intratympanic dexamethasone injection DRUG

intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane

Also known as: intracochlear injection of dexamethasone sodium phosphate through the round window membrane (7.5mg/ml, 30μl) and intratympanic dexamethasone sodium phosphate injection (10mg/ml)

Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection

intratympanic dexamethasone injection DRUG

intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.

Also known as: intratympanic dexamethasone sodium phosphate injection (10mg/ml)

Group D: intratympanic dexamethasone injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment

You may not qualify if:

• Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency The CT diagnosis is "abnormality of the round window niche"

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

Study Sites (1)

Fenyang Road 83

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (13)

• Lv J, Wang H, Cheng X, Chen Y, Wang D, Zhang L, Cao Q, Tang H, Hu S, Gao K, Xun M, Wang J, Wang Z, Zhu B, Cui C, Gao Z, Guo L, Yu S, Jiang L, Yin Y, Zhang J, Chen B, Wang W, Chai R, Chen ZY, Li H, Shu Y. AAV1-hOTOF gene therapy for autosomal recessive deafness 9: a single-arm trial. Lancet. 2024 May 25;403(10441):2317-2325. doi: 10.1016/S0140-6736(23)02874-X. Epub 2024 Jan 24.

  PMID: 38280389 BACKGROUND

• Choi JW, Lee CK, Kim SB, Lee DY, Ko SC, Park KH, Choi SJ. Potential benefits of salvage intratympanic dexamethasone injection in profound idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2219-2227. doi: 10.1007/s00405-020-05967-z. Epub 2020 Apr 15.

  PMID: 32296977 BACKGROUND

• Plontke SK, Biegner T, Kammerer B, Delabar U, Salt AN. Dexamethasone concentration gradients along scala tympani after application to the round window membrane. Otol Neurotol. 2008 Apr;29(3):401-6. doi: 10.1097/MAO.0b013e318161aaae.

  PMID: 18277312 BACKGROUND

• Matsui H, Lopez IA, Ishiyama G, Ishiyama A. Immunohistochemical localization of glucocorticoid receptors in the human cochlea. Brain Res. 2023 May 1;1806:148301. doi: 10.1016/j.brainres.2023.148301. Epub 2023 Mar 1.

  PMID: 36868509 BACKGROUND

• Bird PA, Begg EJ, Zhang M, Keast AT, Murray DP, Balkany TJ. Intratympanic versus intravenous delivery of methylprednisolone to cochlear perilymph. Otol Neurotol. 2007 Dec;28(8):1124-30. doi: 10.1097/MAO.0b013e31815aee21.

  PMID: 18043438 BACKGROUND

• Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.

  PMID: 21610239 BACKGROUND

• Li W, Hartsock JJ, Dai C, Salt AN. Permeation Enhancers for Intratympanically-applied Drugs Studied Using Fluorescent Dexamethasone as a Marker. Otol Neurotol. 2018 Jun;39(5):639-647. doi: 10.1097/MAO.0000000000001786.

  PMID: 29649043 BACKGROUND

• Silverstein H, Choo D, Rosenberg SI, Kuhn J, Seidman M, Stein I. Intratympanic steroid treatment of inner ear disease and tinnitus (preliminary report). Ear Nose Throat J. 1996 Aug;75(8):468-71, 474, 476 passim.

  PMID: 8828271 BACKGROUND

• Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Arch Otolaryngol. 1980 Dec;106(12):772-6. doi: 10.1001/archotol.1980.00790360050013.

  PMID: 7002129 BACKGROUND

• McCabe BF. Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1979 Sep-Oct;88(5 Pt 1):585-9. doi: 10.1177/000348947908800501.

  PMID: 496191 BACKGROUND

• SCHUKNECHT HF. Ablation therapy in the management of Meniere's disease. Acta Otolaryngol Suppl. 1957;132:1-42. No abstract available.

  PMID: 13457879 BACKGROUND

• Fishman JM, Cullen L. Investigating sudden hearing loss in adults. BMJ. 2018 Nov 12;363:k4347. doi: 10.1136/bmj.k4347. No abstract available.

  PMID: 30420423 BACKGROUND

• Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L, Monjur TM. Clinical Practice Guideline: Sudden Hearing Loss (Update) Executive Summary. Otolaryngol Head Neck Surg. 2019 Aug;161(2):195-210. doi: 10.1177/0194599819859883.

  PMID: 31369349 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yilai Shu, MD, Ph.D

  Eye & ENT Hospital, Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li, MD, Ph.D

CONTACT

0086-18301969566; 619liwei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: single blinded (participant and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 21, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)