Data Cut Delivery in Ophthalmology Clinical Trials

This case study outlines the collaboration between Apellis Pharmaceuticals and Fortrea in delivering a critical data cut for a Phase III ophthalmology study. Apellis aimed to investigate the efficacy of SYFOVRE® (pegcetacoplan injection) for treating geographic atrophy, a leading cause of blindness affecting millions. The study required a data cut to be delivered within a month, prompting Fortrea to implement a strategic plan that included increased staffing, tailored reporting, and daily communication with the sponsor. The execution of this plan involved managing two full-service studies across 15 countries and over 200 clinical sites. The successful delivery of the data cut not only met the sponsor's timeline but also contributed to the New Drug Application process for SYFOVRE®, which was ultimately approved by the FDA as the first treatment for geographic atrophy. This partnership exemplifies the importance of effective collaboration and operational agility in clinical research.