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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.
EP: 1.Navigating Step Therapy in nAMD and DME
EP: 2.Role of Biosimilars in nAMD and DME Step Therapy
EP: 3.Overview of the Newest Therapies for AMD and DME: Faricimab and Aflibercept 8mg
EP: 4.Aligning Clinical Trial Retreatment Criteria to Clinical Practice
EP: 5.Perspectives on Retinal Fluid Management in nAMD and DME
EP: 6.Perspectives on Loading Dose and Treatment Extension With New Therapies
EP: 7.Using Steroids in DME Treatment
EP: 8.Patient Selection for New nAMD and DME Therapies
EP: 9.Early Real-World Experiences With Faricimab and Aflibercept 8mg
EP: 10.Safety Considerations for New Therapies
EP: 11.Promoting Treatment Adherence in nAMD and DME
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.
