Key Risk Areas That Can Derail Clinical Trials With Ocular Endpoints

Ophthalmic assessments are increasingly vital in ophthalmic clinical trials, particularly in fields where systemic treatments may impact ocular health. Regulatory agencies, including the FDA, emphasize ophthalmic endpoints, prompting ophthalmic sponsors to integrate these assessments into trial protocols. Key challenges in ophthalmic trials include ensuring baseline and ongoing assessments, utilizing certified equipment, and employing qualified staff to maintain data accuracy and compliance. Trials led by ophthalmic investigators or conducted in geographically remote or resource-limited sites face additional barriers, such as limited access to specialized equipment and personnel. Addressing these hurdles is critical to preserving participant safety, improving diversity, and ensuring trial success.

Proactively mitigating risks through expert collaboration, tailored protocol designs, and point-of-need solutions enhances compliance and trial outcomes. Accurate ophthalmic assessments not only support regulatory approval but also provide essential insights into treatment efficacy and safety, ultimately facilitating the development of innovative therapies and informed patient care decisions.