LIGHTSITE IIIB: Clinical Evaluation of Photobiomodulation (PBM) in dry AMD Patients

LIGHTSITE IIIB：干性 AMD 患者光生物调节 (PBM) 的临床评估

• 批准号: 10602243
• 负责人: CLARK E TEDFORD
• 金额: $ 116.93万
• 依托单位: LUMITHERA, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10602243
• 关键词: Affect; Age; Age related macular degeneration; Anatomy; Antiinflammatory Effect; Applications Grants; Area; Bioenergetics; Blindness; COVID-19; Cell Death; Cell physiology; Cells; Central America; Cessation of life; Clinical; Clinical Trials; Contrast Sensitivity; Country; Data; Developed Countries; Disease; Disease Progression; Dryness; Early treatment; Electroretinography; Enrollment; European Union; Eye; Eye diseases; Feasibility Studies; Grant; Healthcare Systems; Image; Individual; Investigation; Letters; Light; Long-Term Effects; Masks; Measurement; Measures; Medical; Medical Device; Medicine; Metabolic; Mitochondria; Nonexudative age-related macular degeneration; Ophthalmology; Outcome; Outcome Measure; Output; Patients; Perimetry; Persons; Phase; Phototherapy; Placebos; Population; Prevalence; Preventive; Principal Investigator; Quality of life; Randomized, Controlled Trials; Reading; Research Design; Resources; Respiratory Chain; Retina; Retinal Degeneration; Risk; Safety; Scanning; Serious Adverse Event; Site; Small Business Innovation Research Grant; Specific qualifier value; System; Technology; Testing; Time; Tissues; Treatment Protocols; United States; Visit; Visual; Visual Acuity; Visual impairment; Work; age related; cost effective treatment; design; diagnostic strategy; disability; follow-up; fundus imaging; improved; loss of function; luminance; macula; novel; open label; participant enrollment; patient population; photobiomodulation; prevent; prospective; research clinical testing; restorative treatment; slow potential; tissue regeneration; tissue repair; treatment group; treatment strategy

ABSTRACT As the population continues to age, degenerative ocular diseases become increasingly common and create tremendous burden on the health care system. Age-related macular degeneration (AMD) is a progressive ocular disease that causes visual impairment and blindness in its most advanced form and is characterized by loss of function and cell death in the macula, a central and critical part of the retina. Approximately 11 million individuals are affected with AMD in the United States alone, with a global prevalence of 170 million. AMD is the leading cause of visual disability in the developed world and the third leading cause globally. AMD occurs in two forms: dry and wet AMD. Approximately 85-90% of AMD patients have the “dry” form of the disease. Photobiomodulation (PBM) is a low-level light therapy used to induce beneficial cellular processes resulting in significant clinical outcomes, including tissue repair, tissue regeneration and anti- inflammatory effects. At the cellular level, the mechanisms of PBM are ascribed to activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function. LumiThera, Inc. has developed the Valeda® Light Delivery System which delivers multiwavelength PBM for ocular indications. Multiple studies with Valeda now demonstrated improvements in quality of life, clinical, and anatomical outcomes in dry AMD patients. Topline data from the pivotal LIGHTSITE III study (148 eyes; 24-month study design) has met the primary efficacy endpoint demonstrating a statistically significant benefit between PBM and Sham treatment groups, p = 0.003. In addition, a mean 5.5 letter change increase from baseline in visual acuity was seen in the PBM treatment group, P < 0.0001. The current SBIR phase IIB application is to extend the findings from previous SBIR phase I and II studies (SBIR 1R43EY025508-01 and SBIR 1R43EY025508-03) to conduct an open-label, prospective, multi-center extension study in patients that are exiting the main LIGHTSITE III study. The extension will continue to assess the long-term PBM impact on disease progression, safety, and efficacy in subjects with dry AMD (LIGHTSITE IIIB) using Valeda. The study will also be able to compare and establish PBM benefits of early treatment versus delayed treatment by allowing extended PBM treatment for 3 years or starting PBM treatment after 2 years of sham treatment. Specific Aims will establish the magnitude of clinical and anatomical outcome benefits in a longitudinal magnitude for the first time. The grant supports a novel non-invasive, non- pharmaceutical, cost-effective therapy for Dry AMD.

抽象的 随着人口的持续年龄，退化性眼疾病变得越来越普遍 并在医疗系统上创建巨大的伯宁。与年龄相关的黄斑变性（AMD） 是一种进行性眼疾病，会导致其最先进的视觉障碍和失明 形式，其特征是黄斑中的功能和细胞死亡的丧失，黄斑是一个中央和关键的 视网膜的一部分。美国大约有1100万个人受到AMD的影响 仅州，全球患病率为1.7亿。 AMD是视觉残疾的主要原因 在发达国家和全球第三大主要事业中。 AMD以两种形式出现：干燥和 湿的AMD。大约85-90％的AMD患者具有该疾病的“干”形式。 光生物调节（PBM）是一种低级光疗法，用于诱导有益的细胞过程 导致明显的临床结果，包括组织修复，组织再生和抗 - 炎症作用。在细胞水平上，PBM的机制分配给激活 线粒体呼吸链成分导致代谢功能稳定。 Lumithera，Inc。开发了Valeda®轻型输送系统 多波长PBM，用于眼部适应症。现在对Valeda进行了多次研究 干燥AMD患者的生活质量，临床和解剖结局的改善。顶线 来自Pivotal Lights III研究（148眼； 24个月的研究设计）的数据已达到主要 功效端点证明了PBM和假手术之间具有统计学上显着的好处 治疗组，p = 0.003。此外，平均5.5字母更改比基线增加 在PBM治疗组中可以看到敏锐度，p <0.0001。 当前的SBIR IIB阶段应用程序是将发现从以前的SBIR I期扩展到 II研究（SBIR 1R43EY025508-01和SBIR 1R43EY025508-03）进行开放标签， 在退出主灯III的患者中，预期的多中心扩展研究 学习。该扩展将继续评估长期PBM对疾病进展的影响， 安全性，并使用Valeda轻松使用干燥AMD（Lightsite IIIB）的受试者。研究将 还可以比较和建立早期治疗与延迟治疗的PBM益处 通过允许延长PBM治疗3年或在2年后开始PBM治疗 治疗。具体目的将确定临床和解剖结果益处的幅度 首次以纵向幅度。该赠款支持一种新颖的非侵入性，非 - 干燥AMD的药物，具有成本效益的疗法。