Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

NCT04960384 | Completed Phase 2 FDA Drug

• 1 other identifier: 21-00672
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

• TMP Closure Ratio

  Determined by otoscopic exam and photographic documentation

  up to Day 134

Secondary Outcomes (12)

• Time to Closure of TMP

  up to Day 134

• Pure-tone and speech discrimination scores

  Pre-treatment (Day 1)

• Pure-tone and speech discrimination scores

  Post-treatment 1 (Day 22)

• Pure-tone and speech discrimination scores

  Post-treatment 1 (Day 43)

• Pure-tone and speech discrimination scores

  Post-treatment 1 (Day 64)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Human Fibroblast Growth Factor-2 (FGF-2)

EXPERIMENTAL

Drug: FGF-2

Interventions

FGF-2 DRUG

The FGF-2 method of use comprises a pledget of gelatin sponge, with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of fibrin glue used for applications in ear surgery. The concentration of the FGF-2 solution will be 100μg of FGF-2 per 1 mL with an estimated dose of about 20 μg in 0.2ml. Fibrin glue will be applied to secure gelatin sponge after placement according to the size of the membrane perforation. Application of the study treatment will occur at Visit 1 and may be repeated at each follow up visit as needed for a maximum of three treatments in the Randomized Treatment Phase (Visit 1, Visit 2, and Visit 3).

Human Fibroblast Growth Factor-2 (FGF-2)

Placebo DRUG

FGF-2 will be replaced with sterile water to saturate a pledget of gelatin sponge. The method will be otherwise identical to the FGF-2 intervention.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Fibroblast Growth Factor 2

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David Friedmann, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator and the subject will be blinded to treatment assignment during the Randomized Treatment phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: May 27, 2022
• Primary Completion: September 30, 2025
• Study Completion: October 27, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to David.friedmann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)