Clinical Trial: A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.

U.S., May 6 -- ClinicalTrials.gov registry received information related to the study (NCT07568184) titled 'A Randomized Trial of Intratympanic Drug Delivery: Evaluating the Efficacy and Safety of Dexamethasone-Loaded Exosomes Versus Standard Therapy in Acute Sensorineural Hearing Loss.' on April 25.

Brief Summary: Primary Objective To compare the efficacy of a single course of IT Exo-Dex versus conventional IT dexamethasone and exosome vehicle alone, as measured by the mean change in pure-tone average (PTA; 0.5, 1, 2, 4 kHz) from baseline to the 4-week post-treatment endpoint.

Secondary Objectives

1. To determine the safety and tolerability profile of IT Exo-Dex.

2. To compare the rate of hearing recovery (defined as >10 dB improvement ...