Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration

Official title

Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration

Overview

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.

Detailed description

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.

Interventions

• Procedure Photobiomodulation Therapy
  Photobiomodulation (PBM) therapy is delivered using a CE-marked medical device (EYE-LIGHT®, Espansione Group S.p.A., Italy). The treatment consists of two cycles: the first cycle includes 8 sessions over 4 weeks (two sessions per week), and the second cycle includes 6 sessions over 3 weeks. Each session lasts approximately 12 minutes and is performed under standardized conditions. The device delivers low-energy light at specific wavelengths (approximately 590 nm and 630 nm) in both continuous a
• Procedure Sham Photobiomodulation
  The sham intervention is delivered using the same device and procedures as the active photobiomodulation treatment, including identical session number, duration, and schedule, to maintain masking conditions. However, the device delivers minimal, non-therapeutic light energy (approximately 2.5 mW/cm² ±20% and 5.5 mW/cm² ±20%), which is insufficient to produce a biological effect. This approach ensures that participants experience similar treatment conditions without receiving active photobiomodu

Primary outcome measures

• Change in Low-Luminance Visual Acuity (LLVA) [Time frame: Baseline to Month 12]

Secondary outcome measures (9)

• Change in Low-Luminance Contrast Sensitivity (LLCS) [Time frame: Baseline to Month 12]
• Change in Retinal Sensitivity Measured by Microperimetry [Time frame: Baseline to Month 12]
• Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT) [Time frame: Baseline to Month 12]
• Change in Fundus Autofluorescence Patterns [Time frame: Baseline to Month 12]
• Progression to Advanced Age-Related Macular Degeneration [Time frame: Up to Month 12]
• Change in Retinal Perfusion Density Assessed by OCT Angiography [Time frame: Baseline to Month 12]
• Change in Vessel Length Density Assessed by OCT Angiography [Time frame: Baseline to Month 12]
• Change in Foveal Avascular Zone Area Assessed by OCT Angiography [Time frame: Baseline to Month 12]
• Change in Choriocapillaris Flow Deficit Assessed by OCT Angiography [Time frame: Baseline to Month 12]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico — Roma

Identifiers

NCT: NCT07554690 · RET 04-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗