Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

NCT02307916 | Completed Phase 2 Results DMC

• 1 other identifier: 16-043
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

Conditions

Tympanic Membrane Perforation

Keywords

tympanic membrane perforation; ear drum; hole

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Tympanic Membrane Closure Following Treatment

  The efficacy of the treatment is determined by the number of patients whose tympanic membrane perforations closed after study treatments. Subjects from both treatment arms received up to three treatments before determining non-closure of the tympanic membrane.

  ~60 days

Secondary Outcomes (4)

• Measurement of Changes in Pure-tone Averages

  Baseline, 60 days

• Measurement of Changes in Speech Discrimination Scores

  Baseline, 60 days

• Number of Treatments Required for Closure of the Tympanic Membrane Perforation

  60 days

• Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry

  60 days

Study Arms (2)

FGF-2

EXPERIMENTAL

FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.

Drug: FGF-2

Placebo

PLACEBO COMPARATOR

Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.

Other: Placebo

Interventions

FGF-2 DRUG

The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery.

Also known as: FGF2, Human Fibroblast Growth Factor 2

FGF-2

Placebo OTHER

Placebo comparator using a sterile saline solution.

Also known as: Placebo comparator; sterile saline

Placebo

Eligibility Criteria

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

You may qualify if:

• Dry tympanic membrane perforation of greater than 3 months duration
• If female, post-menopausal or sterile, or if she is of child-bearing potential, must have a negative beta-human chorionic gonadotropin (HCG) test and must be using an adequate form of birth control such as birth control pills, birth control implants, intrauterine devices (IUDs), diaphragms or condoms.

You may not qualify if:

• The presence of any of the following excludes a subject from study enrollment:
• 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
• Life expectancy of less than 1 year
• Active alcohol or drug abuse within 6 months prior to study entry
• Known or suspected allergies to any components used in the study
• Subjects who have cholesteatoma mass 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

Sponsors & Collaborators

• D. Bradley Welling, MD, PhD: lead
• United States Department of Defense: collaborator

Study Sites (2)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Wilford Hall, Lackland Airforce Base

Lackland City, Texas, 78236, 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

Results Point of Contact

• Title: Dr. Brad Welling
• Organization: Massachusetts Eye and Ear

brad_welling@meei.harvard.edu

617-573-4075

Study Officials

• D. B. Welling, M.D., Ph.D

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, M.D., Ph.D.

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: October 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: March 1, 2020
• Last Updated: December 8, 2025
• Results First Posted: June 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)