光遗传疗法
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NEJM:人工视网膜,帮助老年性黄斑变性患者恢复视力
生物世界· 2025-10-24 04:04
Core Insights - The article discusses a groundbreaking clinical study published in the New England Journal of Medicine regarding the PRIMA system, a subretinal photovoltaic implant designed to restore vision in patients with geographic atrophy due to age-related macular degeneration (AMD) [2][3]. Group 1: Overview of AMD and PRIMA System - AMD is the most common type of irreversible blindness in the elderly, with dry AMD accounting for 85%-90% of cases, affecting over 5 million people globally [2]. - The PRIMA system, developed by Pixium Vision and acquired by Science Corporation, is a wireless, photovoltaic device implanted under the retina to replace lost photoreceptor cells [3][8]. Group 2: Clinical Study Details - The clinical study involved 38 patients aged 60 and above with advanced dry AMD, who underwent implantation of the PRIMA device and were assessed at 6 and 12 months post-surgery [6]. - After one year, 81% of patients experienced clinically significant improvement in central vision, allowing them to read letters and words, marking a shift from merely slowing disease progression to restoring perception [3][14]. Group 3: PRIMA System Components - The PRIMA system consists of three main components: 1. A subretinal photovoltaic chip measuring 2mm x 2mm and 30 micrometers thick, containing 378 pixel units [10]. 2. Specialized glasses that capture images and project signals to the implant [10]. 3. A portable processor for signal conversion and image adjustment [10]. Group 4: Safety and Efficacy - Among the 32 patients evaluated after 12 months, 26 (81%) showed clinically significant vision improvement, equivalent to seeing two additional lines on a standard vision chart [14]. - A total of 19 participants experienced 26 serious adverse events, with 81% occurring within two months post-surgery, and 95% of these events resolved within the same timeframe [17]. Group 5: Future Directions - The article notes that the PRIMA system is not the only approach being explored for AMD treatment, with ongoing research into stem cell therapy, optogenetics, and brain-machine interfaces to restore vision [17].