Tympanic Membrane PerforationPhase 2NCT04960384
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
A Phase 2 study testing FGF-2 in people with Tympanic Membrane Perforation, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- FGF-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 27 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- FGF-2, Placebo
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGF-2Drug
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Human Fibroblast Growth Factor-2 (FGF-2) | Experimental | Not described Receives: Drug: FGF-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMP Closure Ratio
Determined by otoscopic exam and photographic documentation
Measured: up to Day 134
Secondary outcomes (12)
Time to Closure of TMP
Measured: up to Day 134
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Pre-treatment (Day 1)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 22)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 43)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 64)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 85)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 106)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 127)
Pure-tone and speech discrimination scores
Measured by audiograms (total range of score: 125, 250, 500, 1000, 2000, 4000, 8000 Hz).
Measured: Post-treatment 1 (Day 134)
Air-Bone Gap (ABG)
Defined as the difference between air-conduction and bone-conduction audiometric thresholds
Measured: up to Day 134
Mobility of the Tympanic Membrane
As measured by tympanometry
Measured: Day 134
Salvage Rate of FGF-2 in Patients who Fail Placebo
Measured: Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start27 May 2022
- Primary completion30 Sep 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Friedmann, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960384
- Sponsor's protocol ID
- 21-00672
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only aggregate data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
- ClinicalTrials.gov ID
- NCT04960384
- Acronym / sponsor ID
- 21-00672
- Conditions
- Tympanic Membrane Perforation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Human Fibroblast Growth Factor-2 (FGF-2) | Experimental | Drug: FGF-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FGF-2The 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). | Drug | Human Fibroblast Growth Factor-2 (FGF-2) |
| PlaceboFGF-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. | Drug | Placebo |
Primary outcome
TMP Closure Ratio
Time frame: up to Day 134
Determined by otoscopic exam and photographic documentation
12 secondary outcomes
Time to Closure of TMP
Time frame: up to Day 134
Pure-tone and speech discrimination scores
Time frame: Pre-treatment (Day 1)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 22)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 43)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 64)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 85)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 106)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 127)
Pure-tone and speech discrimination scores
Time frame: Post-treatment 1 (Day 134)
Air-Bone Gap (ABG)
Time frame: up to Day 134
Mobility of the Tympanic Membrane
Time frame: Day 134
Salvage Rate of FGF-2 in Patients who Fail Placebo
Time frame: Day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Only aggregate data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Friedmann, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FGF-2 in people with Tympanic Membrane Perforation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMP Closure Ratio (time frame: up to Day 134). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.