Onset and Progression of Persistent Choroidal Hypertransmission Defects in Intermediate Age-Related Macular Degeneration: A Novel Clinical Trial Endpoint

中文摘要

本研究旨在研究具有中等年齡相關黃斑變性（intermediate age-related macular degeneration, iAMD）的眼睛上可視化的持續性脈絡膜色素超高壁（hypertransmission defects , hyperTDs）的出現和增長，以確定它們是否可作為新的臨床試驗終點。研究中使用6×6mm的光學相干斷層掃描術（OCT）血管成像來觀察眼睛的基線和隨訪檢查期間的變化。結果顯示，使用光學相干斷層掃描術成像可以輕鬆地檢測到持續的hyperTDs，並且其具有高靈敏度、準確性、陽性預測值和評分者間的一致性。該研究還發現，iAMD眼睛中hyperTDs的形成和增大與晚期AMD的發展密切相關。該研究為未來評估可能能夠減緩疾病進展的治療方法提供了新的臨床試驗終點。然而，人們對於超高壁斷層掃描（SS-OCT，SD-OCT）的可用性越來越了解，而更容易取得的SD-OCT儀器能夠生產可以用於檢測和監測超高壁的正面影像。兩者結合起來，持續超高壁的發生和進展可以作為從年齡相關黃斑變性（iAMD）到晚期黃斑變性（AMD）疾病進展的新型臨床試驗終點。

English Abstract

The content discusses a clinical trial that aims to study the onset and progression of persistent choroidal hypertransmission defects (hyperTDs) in intermediate age-related macular degeneration (iAMD). The trial analyzes en face swept-source optical coherence tomography (SS-OCT) images to determine if hyperTDs can serve as novel clinical trial endpoints. The study involves evaluating baseline and follow-up visits of patients with iAMD using SS-OCT angiography imaging. The researchers found that hyperTDs can be detected and studied using en face OCT imaging, and they can potentially be used as endpoints for assessing the effectiveness of therapies to slow the progression of iAMD. The article also discusses the classification of AMD into progressive stages using color fundus imaging and the advantages of using en face OCT imaging in iAMD. Additionally, it explores the methodology, statistical analysis, and the potential implications of the findings in the context of clinical trials and disease progression evaluation.The content discusses the enrollment of subjects in a clinical trial for emerging novel therapies to prevent the enlargement of geographic atrophy (GA). The availability of en face imaging techniques like SS-OCT and SD-OCT can be used to detect and monitor hyperTDs, which can serve as novel clinical trial endpoints to study therapies that may slow disease progression.