Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of Patients With Tympanic Membrane Closure Following Treatment
研究概览
简要总结
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.
详细描述
A Phase II randomized trial will be initiated to evaluate efficacy as the primary measureable outcome. Eligible and consented patients will be randomized in a 3:1 ratio to the optimal biologic dose (OBD) of FGF-2 or placebo (sterile water).
Application of the study treatment may occur at the initial Screening Visit (pending all eligibility requirements can be confirmed) or at Visit 1 and may be repeated at each follow up visit as needed for a maximum of three treatments per treatment arm. These follow up visits will occur three weeks (+/- 7 days) from the last treatment application. During these visits, the subject's tympanic membrane will be examined, photographed, and additional otologic tests will be performed. If the perforation is found to be closed during these visits, 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. Again, the subject may be given up to three additional treatments in this new group. The follow up visits will follow the same schedule, occurring three weeks (+/- 7 days) from the last treatment. The same otologic procedures will be performed as in the previous visits.
All subjects will report for a final study visit 2 months (+/- 7 days) after their last follow up visit when the perforation is determined to be closed or when the subject has completed the maximum number of study visits without perforation closure. The study will be completed for reporting purposes after all subjects have completed the 2 month (+/- 7 days) follow up final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
FGF-2
FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.
干预措施: FGF-2 (Drug)
Placebo
Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Patients With Tympanic Membrane Closure Following Treatment
时间窗: ~60 days
The efficacy of the treatment is determined by the number of patients whose tympanic membrane perforations closed after study treatments. Subjects from both treatment arms received up to three treatments before determining non-closure of the tympanic membrane.
次要结局
- Number of Treatments Required for Closure of the Tympanic Membrane Perforation(60 days)
- Measurement of Changes in Pure-tone Averages(Baseline, 60 days)
- Measurement of Changes in Speech Discrimination Scores(Baseline, 60 days)
- Number of Patients With Normal Mobility of the Eardrum as Assessed by Tympanometry(60 days)
研究者
D. Bradley Welling, MD, PhD
Principal Investigator, M.D., Ph.D.
Massachusetts Eye and Ear Infirmary