Clinical trial NCT04960384: Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Official title: Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Tympanic Membrane Perforation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Dry tympanic membrane perforation of at least 6 months duration
* Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial.

Exclusion Criteria:

* Active otitis media or chronic otorrhea from the middle ear
* Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy
* Subjects who, at study entry, are taking systemic antibiotics
* Subjects who are immunosuppressed
* Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation.
* Life expectancy of less than 1 year
* Active alcohol or drug abuse within 6 months prior to study entry
* Significant medical condition that could prevent full participation in the procedures required for the study
* Known or suspected allergies to any components used in the study, i.e. porcine collagen
* Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity
* Subjects whose total perforation cannot be seen by an endoscope
* Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher)
* Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility
* Subjects who have undergone prior myringoplasty or tympanoplasty
* Subjects whose TMP is a result of thermal burn, or radiation therapy.
* Subjects who have abnormalities in the auditory ossicles or their linkages
* Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia
* Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball.
* Subject having residual TM with abnormal form or abnormal shape anatomically
* Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)

Primary outcomes:
measure: TMP Closure Ratio
timeFrame: up to Day 134
Secondary outcomes:
measure: Time to Closure of TMP
timeFrame: up to Day 134
measure: Pure-tone and speech discrimination scores
timeFrame: Pre-treatment (Day 1)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 22)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 43)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 64)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 85)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 106)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 127)
measure: Pure-tone and speech discrimination scores
timeFrame: Post-treatment 1 (Day 134)
measure: Air-Bone Gap (ABG)
timeFrame: up to Day 134
measure: Mobility of the Tympanic Membrane
timeFrame: Day 134
measure: Salvage Rate of FGF-2 in Patients who Fail Placebo
timeFrame: Day 64
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Friedmann, MD
role: PRINCIPAL_INVESTIGATOR
References: