FGF Regeneration of TMP

 

Title

Fibroblast Growth Factor (FGF) Regeneration of Tympanic Membrane Perforations

MEEI Protocol ID

16-043H

National Clinical Trial (NCT) Number

NCT02307916

Condition

Tympanic Membrane Perforation (TMP)

Sponsor

Department of Defense

Principal Investigator

Brad Welling, MD, PhD

Study Design

Phase 2, Randomized Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Study Objective

Primary:

  • Efficacy of the optimal biologic dose (OBD) of FGF-2 on closure of tympanic membrane perforations

Secondary:

  • Measurement of changes in pure-tone and speech discrimination scores measured by pre- and post-treatment audiograms and the mobility of the tympanic membrane as measured by tympanometry.
  • Determination of the time to closure of tympanic membrane perforation
  • Determination mobility of tympanic membrane measured by tympanometry pre and post treatment

Who is Eligible

Inclusion Criteria:

  • 18 years or older
  • 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 (HCG) test and must be using an adequate form of birth control.

Exclusion Criteria:

Any of the following excludes a subject from study enrollment:

  • Active otitis media or chronic otorrhea from the middle ear
  • Subjects who are:
    • receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy
    • taking systemic antibiotics
    • immunosuppressed
    • 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
  • 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
  • Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility

Subject Enrollment

60 Adult Study Participants

Study Procedures

First visit: study treatment will be applied directly to the TMP using a gelfoam (soaked with the treatment solution) and small amount of adhesive.
Follow-up visits: Study treatment application may be repeated for a maximum of three (3) treatments; each visit occurring three weeks (+/- 7 days) from the last treatment application.  The subject's tympanic membrane will be examined, photographed, and additional otologic tests will be performed. If the perforation is found to be closed, then the subject will report in 2 months (+/-7 days) for a final study visit.  If the subject's TMP has not closed after the third and final application of their assigned treatment group, then the subject will be crossed over to the other treatment group. The subject may be given up to three (3) additional treatments in this new group. The follow up visits will follow the same schedule as previous follow-up visits. The same otologic procedures will be performed as in the previous visits.

For More Information

Amy_Quinkert@meei.harvard.edu

 

 

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Page updated 12/21/2016.