Aligning Clinical Trial Retreatment Criteria to Clinical Practice
Judy Kim, MD and Peter Kaiser, MD reflect on the varying criteria for shortening or extending treatment intervals in clinical trials, emphasizing the need for standardization in large-scale studies. They highlight the importance of adapting trial criteria to clinical practice.
Summary
Experts discuss the variation in extension and shortening criteria across clinical trials for newer therapies in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Judy Kim, MD cites examples from PULSAR and PHOTON trials, highlighting specific criteria such as visual acuity and central subfield thickness changes for shortening intervals. Peter Kaiser, MD acknowledges the complexity of these criteria and emphasizes the need for standardization in large-scale clinical studies. In clinical practice, Kaiser points out that decisions on shortening or extending treatment intervals are based on a more intuitive approach, considering factors like vision loss, optical coherence tomography changes, and the patient's overall response. Kaiser emphasizes that, unlike clinical trials, where strict criteria are defined, the real-world application involves a more flexible and personalized approach.
The conversation underscores the importance of clinical trial standardization while acknowledging the practical challenges of applying rigid criteria in day-to-day patient care. Experts highlight the need for a personalized "treat and extend" approach based on fluid status, previous durability, and vision outcomes.
This summary was AI-generated and edited for clarity.
