Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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. 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.