Archway 第三階段試驗 – 使用Ranibizumab的港口藥物傳遞系統對於新生血管相關的老年黃斑變性病症兩年結果

Tags Retina
Journal Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

Ophthalmology Volume 130, Number 7, July 2023


這篇文章討論了Archway Phase 3試驗的2年結果,該試驗評估了Port Delivery System(PDS)與ranibizumab治療新生血管性老年性黃斑變性(nAMD)。試驗納入了先前接受過抗VEGF治療並有對治療產生反應的nAMD患者。研究發現,PDS組和每月ranibizumab組均報告了特定興趣的眼部不良事件(adverse event of special interest, AESI),其中白內障是最常見的AESI。這些不良事件是可以控制的,並且努力減少了與PDS相關的不良事件。試驗還評估了視覺結果,發現兩種治療方法在最佳矯正視力(BCVA)基準的改變方面基本上是相似的。研究結論是通過PDS連續提供ranibizumab在2年期間對nAMD患者帶來了持續的益處。延長試驗將收集額外的長期資料,覆蓋長達5年的時間

English Abstract

Title : Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results

The article discusses the 2-year results of the Archway Phase 3 Trial, which evaluated the Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD). The trial included patients with previously treated nAMD who had a documented response to anti-VEGF treatment. The study found that ocular adverse events of special interest (AESI) were reported in both the PDS and monthly ranibizumab groups, with cataract being the most common AESI. The AESIs were manageable, and efforts were made to minimize PDS-related adverse events. The trial also assessed visual outcomes and found that the change from baseline in best-corrected visual acuity (BCVA) was generally similar between the two treatment arms. The study concluded that the continuous delivery of ranibizumab through the PDS provided consistent benefits to patients with nAMD over a 2-year period. Additional long-term data up to 5 years are being collected in an extension trial.