LIGHTSITE II随机多中心试验：非渗出性年龄相关性黄斑变性的多波长光生物调节评估
LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.
作者信息
Burton Ben, Parodi Maurizio Battaglia, Jürgens Ignasi, Zanlonghi Xavier, Hornan Dan, Roider Johann, Lorenz Katrin, Munk Marion R, Croissant Cindy L, Tedford Stephanie E, Walker Michael, Ruckert Rene, Tedford Clark E
机构信息
James Paget University, Great Yarmouth, UK.
Department of Ophthalmology, Vita-Salute San Raffaele University, Istituto Scientifico Ospedale San Raffaele IRCSS, Milan, Italy.
出版信息
Ophthalmol Ther. 2023 Apr;12(2):953-968. doi: 10.1007/s40123-022-00640-6. Epub 2023 Jan 2.
INTRODUCTION
Photobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses wavelengths of light to target components of the mitochondrial respiratory chain to improve cellular bioenergetic outputs. The aim of this study was to further investigate the effects of PBM on clinical, quality of life (QoL) and anatomical outcomes in subjects with intermediate stage non-exudative AMD.
METHODS
The multicenter LIGHTSITE II study was a randomized clinical trial evaluating safety and efficacy of PBM in intermediate non-exudative AMD. The LumiThera Valeda® Light Delivery System delivered multiwavelength PBM (590, 660 and 850 nm) or sham treatment 3 × per week over 3-4 weeks (9 treatments per series) with repeated treatments at baseline (BL), 4 and 8 months. Subjects were enrolled with 20/32 to 20/100 best-corrected visual acuity (BCVA) and no central geographic atrophy (GA) within the central fovea (500 μm).
RESULTS
LIGHTSITE II enrolled 44 non-exudative AMD subjects (53 eyes). PBM-treated eyes showed statistically significant improvement in BCVA at 9 months (n = 32 eyes, p = 0.02) with a 4-letter gain in the PBM-treated group versus a 0.5-letter gain in the sham-treated group (ns, p < 0.1) for patients that received all 27 PBM treatments (n = 29 eyes). Approximately 35.3% of PBM-treated eyes showed ≥ 5-letter improvement at 9 months. Macular drusen volume was not increased over time in the PBM-treated group but did show increases in the sham-treated group. While PBM and sham groups both showed GA lesion growth in the trial period, there was 20% less growth in the PBM group over 10 months, suggesting potential disease-modifying effects. No safety concerns or signs of phototoxicity were observed.
CONCLUSION
These results confirm previous clinical testing of multiwavelength PBM and support treatment with Valeda as a novel therapy with a unique mechanism of action as a potential treatment for non-exudative AMD.
TRIAL REGISTRATION
Clinicaltrial.Gov Registration Identifier: NCT03878420.
引言
光生物调节（PBM）是一种治疗非渗出性年龄相关性黄斑变性（AMD）的潜在方法。PBM利用特定波长的光靶向线粒体呼吸链的组成部分，以提高细胞生物能量输出。本研究的目的是进一步探讨PBM对中度非渗出性AMD患者的临床、生活质量（QoL）和解剖学结果的影响。
方法
多中心LIGHTSITE II研究是一项评估PBM在中度非渗出性AMD中的安全性和有效性的随机临床试验。LumiThera Valeda®光输送系统每周进行3次多波长PBM（590、660和850nm）治疗或假治疗，持续3-4周（每个疗程9次治疗），并在基线（BL）、4个月和8个月时重复治疗。入组患者的最佳矫正视力（BCVA）为20/32至20/100，且中央凹（500μm）内无中心性地理萎缩（GA）。
结果
LIGHTSITE II研究纳入了44例非渗出性AMD患者（53只眼）。接受全部27次PBM治疗的患者（n = 29只眼）中，PBM治疗组的眼睛在9个月时BCVA有统计学意义的改善（n = 32只眼, p = 0.02），PBM治疗组视力提高了4个字母，而假治疗组提高了0.5个字母（无统计学差异, p < 0.1）。约35.3%接受PBM治疗的眼睛在9个月时视力改善≥5个字母。PBM治疗组的黄斑玻璃疣体积未随时间增加，而假治疗组则有增加。虽然PBM组和假治疗组在试验期间均出现GA病变进展，但PBM组在10个月内的进展减少了20%，提示可能具有疾病修饰作用。未观察到安全问题或光毒性迹象。
结论
这些结果证实了先前对多波长PBM的临床测试，并支持将Valeda作为一种具有独特作用机制的新型疗法用于治疗非渗出性AMD。
试验注册
Clinicaltrial.Gov注册号：NCT03878420。
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