Considerations in Eligibility Criteria for Delivery of Successful Retinal Studies

By Raymond Cook, MD, Vice President Internal Medicine, Kathleen Gordon, MD, Sr. Medical Director, Ophthalmology Center of Excellence and Mark Herring, Clinical Project Management Director

Designing eligibility criteria for retinal studies is a critical step that directly impacts recruitment, data integrity, and trial success. Retinal disorders often involve heterogeneous patient populations and complex disease progression, making precise inclusion and exclusion parameters essential. Overly restrictive criteria can slow enrollment and limit generalizability, while overly broad criteria risk introducing variability that compromises outcomes.

Key considerations include aligning eligibility with disease stage, prior treatments, and comorbidities, as well as incorporating imaging and biomarker data for accurate diagnosis. Sponsors should also evaluate geographic and demographic factors to ensure diversity and representation. Balancing scientific rigor with operational feasibility requires a strategic approach that anticipates regulatory expectations and patient burden.

Explore practical frameworks for optimizing eligibility criteria to accelerate recruitment and deliver meaningful results in retinal clinical development. Access the full resource to learn how to refine eligibility strategies and improve trial efficiency for retinal therapies.