Safety and Efficacy of Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The mean change in BCVA measured by ETDRS chart
研究概览
简要总结
This prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in patients with dry age-related macular degeneration (AMD). The primary objective is to assess the effect of RLRL therapy on visual function in patients with dry AMD, while the secondary objective is to evaluate its safety and tolerability.
Seventy-four participants aged 50 years or older with dry AMD will be enrolled and randomly assigned in a 1:1 ratio to either the active RLRL intervention group (using the full device power) or the control group (sham device at 10% power). Group assignments will be masked to both participants and investigators. Participants will administer the treatment at home twice daily (3-minute sessions, with at least a 4-hour interval between sessions) over five consecutive weekdays each month for three months. A video tutorial will guide device usage, with ongoing support from the research team.
Before enrollment, participants will undergo a comprehensive assessment, including ocular and family history review, OCT, and fundus photography to confirm eligibility. Evaluations will occur at baseline, 1 month, and 3 months, covering best-corrected visual acuity (BCVA), slit-lamp examination, OCT, OCT angiography (OCTA), fundus autofluorescence (FAF), contrast sensitivity, color vision, electroretinography (ERG), visual-related quality of life (VRQL) questionnaires, and adverse event monitoring.
The primary outcome is the mean change in BCVA from baseline to 3 months. Secondary outcomes include changes in central drusen thickness, geographic atrophy (GA) size and progression, choroidal blood flow, contrast sensitivity, ERG responses, and VRQL scores.
Given the limited treatment options for dry AMD, which are primarily focused on lifestyle changes and nutritional supplements, this study investigates the potential of RLRL therapy as a novel, non-invasive treatment. The results may address the unmet medical need in dry AMD, potentially slowing disease progression and improving patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years old.
- •Diagnosis of dry AMD in Age-Related Eye Disease Study (AREDS) category 2 to 4, as determined by color fundus photography and fundus autofluorescence imaging. The AREDS categories will be defined as follows:
- •i) AREDS category 2 (early AMD): Multiple small drusen, a few intermediate drusen (63-124 μm in diameter), or retinal pigment epithelium (RPE) abnormalities ii) AREDS category 3 (intermediate AMD): Extensive intermediate drusen, including at least one large drusen (> 125 μm in diameter), or geographic atrophy (GA) not involving the center of the fovea.
- •iii) AREDS category 4 (advanced/late AMD): GA involving the center of the macula.
- •If both eyes meet the inclusion criteria, both eyes will be included in the study analysis.
- •ETDRS BCVA score between 50 and 75 (Snellen equivalent of 20/32 to 20/100). Willingness to provide written informed consent after being informed of the nature of the study.
排除标准
- •Previous or active neovascular maculopathy.
- •Presence of center involving GA within the central 500 μm of the ETDRS grid.
- •Ocular disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina macular dystrophy), or mitochondrial disorders (parafoveal petaloid GA, Stargardt disease).
- •Invasive eye surgery (e.g. cataract extraction, capsulotomy) within 3 months.
- •Cognitive impairment or history of epilepsy.
- •Other significant ocular disease affecting visual acuity (e.g., diabetic macular edema, uncontrolled glaucoma, active uveitis, vitreoretinal disease, intraocular tumor, retinal vascular disease, lens opacities more severe than C2, N2, P2 [LOCS III]).
- •Afterimage > 5 min (contraindication of red-light therapy).
研究组 & 干预措施
RLRL therapy group
The RLRL therapy group will undergorepeated low-level red-light therapy (RLRL).The light power through a 4-mm pupil is 0.29 mW for the RLRL device.
干预措施: RLRL device (Device)
Sham therapy group
The sham therapy group will use a sham device, which operates at only 10% of the active RLRL device's power. The light power through a 4-mm pupil is 0.03mW for the sham device.
干预措施: Sham device (Device)
结局指标
主要结局
The mean change in BCVA measured by ETDRS chart
时间窗: At 1month and 3 months compared to baseline
An Early Treatment Diabetic Retinopathy Study (ETDRS) chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will be used to measure distance visual acuity. Best corrected visual acuity and uncorrected visual acuity will be measured.
次要结局
- Change in central drusen volume measured by optical coherence tomography (OCT)(At 1month and 3 months compared to baseline)
- Change in central drusen thickness measured by optical coherence tomography (OCT).(At 1month and 3 months compared to baseline)
- Change in retinal sensitivity using microperimetry.(At 1month and 3 months compared to baseline)
- Outcomes of visual-related quality of life (VRQL) assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25)(At 3 months compared to baseline)
- Size of GA assessed by fundus autofluorescence (FAF) imaging(At 1month and 3 months compared to baseline)
- Change in contrast sensitivity using the Mars Letter Contrast Sensitivity Test(At 1month and 3 months compared to baseline)