Clinical Trial Methodology to Evaluate Safety and Efficacy of Hyaluronidase in Clearance of Vitreous Hemorrhage

摘要: Vitrase [R](Hyaluronidase), an investigational drug developed to facilitate clearance of vitreous hemorrhage, is currently in Phase III trials to evaluate safety and efficacy for clearance of severe vitreous hemorrhage. In order to design the current trials, data were analyzed on rate and frequency of clinically significant hemorrhage clearance through two months following intravitreal injection of this hyaluronidase from two previous Phase II multi-centered trials involving 378 subjects, the majority of whom had proliferative diabetic retinopathy. Based on the Phase II trial results, inclusion and exclusion criteria for the Phase III trials were established. Primary and secondary endpoints were developed in collaboration with the FDA. Grading scales for vitreous hemorrhage density and treatment were developed for both entry criteria and endpoint analysis. Two Phase III multi-centered, prospective, randomized, double-masked …