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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
Must not have
Subjects whose TMP is a result of thermal burn, or radiation therapy
Subjects who have abnormalities in the auditory ossicles or their linkages
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment 1 (day 134)

Summary

This trial tests FGF-2, a protein that helps heal tissues, on patients with chronic ear drum holes that don't heal naturally. FGF-2 works by promoting new cell growth and tissue repair to close the holes. FGF-2 has been widely used for burn treatment and wound healing due to its ability to stimulate cell growth and repair.

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.
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.
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
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I am 18 years old or older.
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I have had a hole in my eardrum for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tissue damage is due to a burn or radiation therapy.
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I have issues with the bones in my ear.
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I have a growth or invasion in my ear's inner parts.
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I am currently on radiation, steroids, immunosuppressants, or chemotherapy.
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I currently have an ear infection or chronic ear discharge.
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I am currently taking antibiotics.
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I have a tumor with an abnormal shape or form.
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I have had surgery to repair my eardrum.
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My diabetes is not well-controlled (HbA1c 6.9% or higher).
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I have moderate to severe dementia, like Alzheimer's.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
TMP Closure Ratio
Secondary study objectives
Air-Bone Gap (ABG)
Mobility of the Tympanic Membrane
Pure-tone and speech discrimination scores

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
1,408 Previous Clinical Trials
855,693 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
~2 spots leftby Jan 2025
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