Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in Low-Luminance Visual Acuity (LLVA)
研究概览
简要总结
This study evaluates whether a low-energy laser treatment called photobiomodulation (PBM) can improve visual function and retinal structure in patients with age-related macular degeneration (AMD) who have reticular pseudodrusen. PBM is a non-invasive therapy that uses specific wavelengths of light to stimulate cellular activity and reduce inflammation without causing tissue damage.
Participants will be randomly assigned to receive either active PBM treatment or a sham (inactive) treatment. The study will assess changes in visual performance under low-light conditions and retinal structure over a 12-month period.
The goal is to determine whether PBM can slow disease progression and improve visual function in patients with early stages of AMD.
详细描述
This is a prospective, randomized, single-center interventional clinical study designed to evaluate the efficacy of photobiomodulation (PBM) laser therapy in patients with reticular pseudodrusen associated with intermediate age-related macular degeneration (AMD).
PBM is a non-invasive treatment that uses low-energy light to modulate cellular activity, improve mitochondrial function, and reduce oxidative stress and inflammation, which are key mechanisms involved in AMD progression. Although previous studies have shown promising results, evidence remains heterogeneous and further investigation is needed, particularly regarding functional outcomes.
Participants will be randomly assigned in a 2:1 ratio to receive either active PBM treatment or sham treatment. The intervention consists of two treatment cycles delivered over several weeks, using a CE-marked medical device. Each session includes exposure to specific wavelengths of light under standardized conditions.
The study focuses on both functional and structural outcomes. Functional assessments include low-luminance visual acuity, contrast sensitivity, and microperimetry, while structural changes are evaluated using multimodal retinal imaging techniques such as spectral-domain optical coherence tomography, fundus autofluorescence, and OCT angiography.
Participants will be followed for 12 months to assess changes from baseline and compare outcomes between the treatment and control groups. The study aims to determine whether PBM therapy can improve visual function and potentially slow disease progression in patients with early stages of AMD.
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
- Single (Participant)
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
- •Diagnosis of reticular pseudodrusen secondary to age-related macular degeneration in the study eye
- •Best-corrected visual acuity (BCVA) between 20/20 and 20/400 (inclusive)
- •Ability and willingness to comply with study procedures and visits
- •Written informed consent obtained prior to any study procedures
排除标准
- •Presence of geographic atrophy
- •Evidence of macular neovascularization
- •Any previous treatment for age-related macular degeneration, except for antioxidant supplementation
- •Media opacities that may interfere with retinal imaging assessments
- •Use of phototoxic medications (including certain antibiotics or chemotherapeutics) during PBM treatment
- •Any ocular or systemic treatment known to be toxic to the retina or optic nerve
- •History of uveitis (idiopathic or autoimmune)
- •Neovascular glaucoma
- •Glaucoma due to congenital anomalies
- •Glaucoma secondary to active uveitis
- •Any intraocular surgery within 3 months prior to enrollment in the study eye
- •Previous thermal laser treatment in the macular region of the study eye
- •History of vitrectomy, filtering surgery, corneal transplantation, or retinal detachment in the study eye
- •Previous therapeutic radiation to the ocular region or face
- •Women of childbearing potential not using effective contraception during the study treatment period
研究组 & 干预措施
Photobiomodulation (PBM) Laser Treatment
Participants assigned to this arm will receive photobiomodulation (PBM) therapy using a CE-marked medical device. Treatment is delivered in two cycles: the first cycle consists of 8 sessions over 4 weeks (two sessions per week), and the second cycle consists of 6 sessions over 3 weeks. Each session lasts approximately 12 minutes and includes exposure to specific wavelengths of light under standardized conditions.
干预措施: Photobiomodulation Therapy (Procedure)
Sham Treatment
Participants assigned to this arm will undergo sham treatment following the same schedule and procedures as the active treatment group, including identical session frequency and duration. The device delivers minimal, non-therapeutic light energy, ensuring no active photobiomodulation effect while maintaining masking conditions.
干预措施: Sham Photobiomodulation (Procedure)
结局指标
主要结局
Change in Low-Luminance Visual Acuity (LLVA)
时间窗: Baseline to Month 12
Low-luminance visual acuity (LLVA) will be assessed as the change from baseline to Month 12, measured using standardized ETDRS charts under low-luminance conditions. The analysis will compare the mean change between the photobiomodulation treatment group and the sham control group.
次要结局
- Change in Low-Luminance Contrast Sensitivity (LLCS)(Baseline to Month 12)
- Change in Retinal Sensitivity Measured by Microperimetry(Baseline to Month 12)
- Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT)(Baseline to Month 12)
- Progression to Advanced Age-Related Macular Degeneration(Up to Month 12)
- Change in Fundus Autofluorescence Patterns(Baseline to Month 12)
- Change in Retinal Perfusion Density Assessed by OCT Angiography(Baseline to Month 12)
- Change in Vessel Length Density Assessed by OCT Angiography(Baseline to Month 12)
- Change in Foveal Avascular Zone Area Assessed by OCT Angiography(Baseline to Month 12)
- Change in Choriocapillaris Flow Deficit Assessed by OCT Angiography(Baseline to Month 12)