近日，德国波恩大学Frank G. Holz团队研究了用于治疗AMD所致地图状萎缩的视网膜下光伏植入器视力重建方案的疗效与安全性。相关论文于2025年10月20日发表在《新英格兰医学杂志》上。

由年龄相关性黄斑变性（AMD）引起的地图状萎缩是导致不可逆性失明的主要原因，影响着全世界500多万人。目前还没有治疗方法来恢复这些人的视力。光伏视网膜植入微阵列（PRIMA）系统结合了视网膜下光伏植入物和向植入物投射近红外光的眼镜，以恢复视网膜中央萎缩区域的视力。

研究组进行了一项开放标签、多中心、前瞻性、单组、基线对照的临床研究，在该研究中，患有地图状萎缩且视力至少为1.2 logMAR（最小分辨角的对数）的参与者在6个月和12个月时使用PRIMA眼镜和不使用PRIMA眼镜评估视力。主要终点是从基线到植入后12个月有临床意义的视力改善（定义为≥0.2 logMAR），以及到12个月与手术或设备相关的严重不良事件的数量和严重程度。

结果:共有38名参与者接受了PRIMA种植体，其中32人在12个月时进行了评估。在未接受评估的6名参与者中，3人死亡，1人退出，2人无法进行测试。在完成12个月随访的32名参与者中，PRIMA系统导致26名患者的视力较基线有临床意义的改善（81%；95%置信区间，64 - 93;P<0.001）。研究团队使用多重输入来解释6名数据缺失的参与者，估计所有参与者中有80% （95% CI， 66至94；P<0.001）在12个月时有临床意义的改善。19名受试者共发生26次严重不良事件。其中21例（81%）发生在术后2个月内，其中20例（95%）在发病后2个月内消退。植入术后平均自然周边视力与基线相当。

研究结果表明，在这项涉及38名因AMD而出现地图状萎缩的参与者的研究中，PRIMA系统恢复了中心视力，并导致视力从基线到第12个月的显著改善。

附：英文原文

Title: Subretinal Photovoltaic Implant to Restore Vision in Geographic Atrophy Due to AMD

Author: Frank G. Holz, Yannick Le Mer, Mahiul M.K. Muqit, Lars-Olof Hattenbach, Andrea Cusumano, Salvatore Grisanti, Laurent Kodjikian, Marco Andrea Pileri, Frederic Matonti, Eric Souied, Boris V. Stanzel, Peter Szurman, Michel Weber, Karl Ulrich Bartz-Schmidt, Nicole Eter, Marie Noelle Delyfer, Jean Franois Girmens, Koen A. van Overdam, Armin Wolf, Ralf Hornig, Martina Corazzol, Frank Brodie, Lisa Olmos de Koo, Daniel Palanker, José-Alain Sahel

Issue&Volume: 2025-10-20

Abstract:

BACKGROUND

Geographic atrophy due to age-related macular degeneration (AMD) is the leading cause of irreversible blindness and affects more than 5 million persons worldwide. No therapies to restore vision in such persons currently exist. The photovoltaic retina implant microarray (PRIMA) system combines a subretinal photovoltaic implant and glasses that project near-infrared light to the implant in order to restore sight to areas of central retinal atrophy.

METHODS

We conducted an open-label, multicenter, prospective, single-group, baseline-controlled clinical study in which the vision of participants with geographic atrophy and a visual acuity of at least 1.2 logMAR (logarithm of the minimum angle of resolution) was assessed with PRIMA glasses and without PRIMA glasses at 6 and 12 months. The primary end points were a clinically meaningful improvement in visual acuity (defined as ≥0.2 logMAR) from baseline to month 12 after implantation and the number and severity of serious adverse events related to the procedure or device through month 12.

RESULTS

A total of 38 participants received a PRIMA implant, of whom 32 were assessed at 12 months. Of the 6 participants who were not assessed, 3 had died, 1 had withdrawn, and 2 were unavailable for testing. Among the 32 participants who completed 12 months of follow-up, the PRIMA system led to a clinically meaningful improvement in visual acuity from baseline in 26 (81%; 95% confidence interval, 64 to 93; P<0.001). Using multiple imputation to account for the 6 participants with missing data, we estimated that 80% (95% CI, 66 to 94; P<0.001) of all participants would have had a clinically meaningful improvement at 12 months. A total of 26 serious adverse events occurred in 19 participants. Twenty-one of these events (81%) occurred within 2 months after surgery, of which 20 (95%) resolved within 2 months after onset. The mean natural peripheral visual acuity after implantation was equivalent to that at baseline.

CONCLUSIONS

In this study involving 38 participants with geographic atrophy due to AMD, the PRIMA system restored central vision and led to a significant improvement in visual acuity from baseline to month 12.

DOI: NJ202510200000015

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2501396