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Growth Factor

FGF-2 for Ear Drum Perforation

Phase 2
Recruiting
Led By David Friedmann, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Dry tympanic membrane perforation of at least 6 months duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment 1 (day 134)
Awards & highlights

Study Summary

This trial is testing whether or not a growth factor called FGF-2 can help heal chronic non-healing tympanic membrane perforations (TMP). The main way they will measure efficacy is by documentation of TM closure. The study will have two phases- during the first phase, subjects will be randomly assigned to receive FGF-2 or placebo, and in the second phase, subjects who did not respond to the initial treatment will receive the other treatment.

Who is the study for?
Adults over 18 with chronic ear drum perforations lasting at least 6 months can join. They must not be pregnant, agree to birth control use, and have no severe diabetes, ear shape abnormalities, active middle ear infections or recent substance abuse. Those on certain medications like antibiotics or with conditions affecting participation are excluded.Check my eligibility
What is being tested?
The trial is testing FGF-2's ability to heal long-term tympanic membrane (ear drum) perforations versus a placebo. It's double-blinded: neither doctors nor patients know who gets real treatment. If the placebo fails after three tries, those patients get FGF-2 in an unblinded crossover phase.See study design
What are the potential side effects?
While specific side effects of FGF-2 aren't listed here, common ones for similar treatments may include local irritation or infection at the application site, allergic reactions to components used in the study such as porcine collagen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have had a hole in my eardrum for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment 1 (day 134)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment 1 (day 134) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
TMP Closure Ratio
Secondary outcome measures
Air-Bone Gap (ABG)
Mobility of the Tympanic Membrane
Pure-tone and speech discrimination scores
+2 more

Side effects data

From 2020 Phase 2 trial • 57 Patients • NCT02307916
12%
Ear infection
12%
Ear drainage post-treatment
7%
Ear pain during procedure
100%
80%
60%
40%
20%
0%
Study treatment Arm
FGF-2
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Human Fibroblast Growth Factor-2 (FGF-2)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FGF-2
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,372 Previous Clinical Trials
841,060 Total Patients Enrolled
David Friedmann, MDPrincipal InvestigatorNYU Langone Health

Media Library

FGF-2 (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT04960384 — Phase 2
Ear Drum Perforation Research Study Groups: Placebo, Human Fibroblast Growth Factor-2 (FGF-2)
Ear Drum Perforation Clinical Trial 2023: FGF-2 Highlights & Side Effects. Trial Name: NCT04960384 — Phase 2
FGF-2 (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04960384 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively enrolling new participants?

"Data available on clinicaltrials.gov demonstrates that this experiment is actively seeking new participants since its initial posting on May 27th 2022 and subsequent editing on June 7th 2022."

Answered by AI

Does FGF-2 pose any risk to patients when administered?

"Although FGF-2 has only been tested on a limited basis for its safety, it received an estimation of 2 out of 3 due to the Phase 2 trial data that supports it."

Answered by AI

How many individuals is this trial recruiting?

"Affirmative. According to the information hosted by clinicaltrials.gov, this investigation is actively seeking out volunteers, having been initially posted on May 27th of 2022 and most recently updated on June 7th of that same year. 70 individuals from a single site are necessary for completion of the trial."

Answered by AI

Are there other investigations that have taken place regarding FGF-2?

"Currently, 3 clinical trials are running to evaluate the efficacy of FGF-2. None of these active studies have advanced to Phase 3 yet and most locations for testing this treatment can be found in Nanjing, Jiangsu; though there is a total of three sites supporting these experiments."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
2022. "Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04960384.
~11 spots leftby Jan 2025
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