Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Status Recruiting

Clinical Trial Summary

This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Tympanic Membrane Perforation

Clinical Trial Details

NCT number	NCT04960384
Study type	Interventional
Source	NYU Langone Health
Contact	Ashley Feng
Phone	212-263-6344
Email	Ashley.Feng@nyulangone.org
Status	Recruiting
Phase	Phase 2
Start date	May 27, 2022
Completion date	June 2025

View Details

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