Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Completed · Phase 2 · Has a placebo group

Conditions studied: Tympanic Membrane Perforation

In brief

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.

Key facts

Study ID

NCT02307916

Run by

D. Bradley Welling, MD, PhD

People needed

57

Starts

2016-10-01

Expected to finish

2020-03-01

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Significant medical condition that could prevent full participation in the procedures required for the study (See body of protocol for full list of exclusions)
• 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

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States
• Wilford Hall, Lackland Airforce Base — Lackland City, Texas, United States

Full record on ClinicalTrials.gov

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