LIGHTSITE III：使用Lumithera Valeda光传输系统对非渗出性（干性）年龄相关性黄斑变性进行多波长光生物调节的13个月疗效和安全性评估。

LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System.

作者信息

Boyer David, Hu Allen, Warrow David, Xavier Samantha, Gonzalez Victor, Lad Eleonora, Rosen Richard B, Do Diana, Schneiderman Todd, Ho Allen, Munk Marion R, Jaffe Glenn, Tedford Stephanie E, Croissant Cindy L, Walker Michael, Rückert Rene, Tedford Clark E

机构信息

Retina Vitreous Associates Medical Group, Beverly Hills, California.

Cumberland Valley Retina Consultants, Hagerstown, Maryland.

出版信息

Retina. 2024 Mar 1;44(3):487-497. doi: 10.1097/IAE.0000000000003980.

DOI:10.1097/IAE.0000000000003980

PMID:37972955

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10885856/

Abstract

PURPOSE

The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System.

METHODS

LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report.

RESULTS

A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy best-corrected visual acuity endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 to -0.1, P = 0.02) (PBM alone: 5.4 letters (SE 0.96), CI: 3.5 to 7.3, P < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7-5.2, P < 0.0001). The PBM group showed a significant decrease in new onset geographic atrophy ( P = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed.

CONCLUSION

LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM therapy.

摘要

目的

LIGHTSITE III研究使用LumiThera Valeda光传递系统评估了多波长光生物调节（PBM）疗法在非渗出性（干性）年龄相关性黄斑变性（AMD）中的效果。

方法

LIGHTSITE III是一项随机对照试验，旨在评估PBM在干性AMD中的安全性和有效性。受试者接受多波长PBM（590、660和850纳米）或假治疗，每四个月进行一系列共九次治疗，为期3至5周，持续24个月。对受试者进行疗效和安全性评估。本报告呈现了13个月分析的数据。

结果

共有100名干性AMD受试者（148只眼）被随机分组。LIGHTSITE III达到了主要疗效最佳矫正视力终点，PBM组（n = 91只眼）和假治疗组（n = 54只眼）之间存在显著差异（组间差异：2.4个字母（标准误1.15），置信区间：-4.7至-0.1，P = 0.02）（单独PBM：5.4个字母（标准误0.96），置信区间：3.5至7.3，P < 0.0001；单独假治疗：3.0个字母（标准误1.13），置信区间：0.7 - 5.2，P < 0.0001）。PBM组新发地图样萎缩显著减少（P = 0.024，Fisher精确检验，优势比9.4）。观察到良好的安全性。