Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration

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.

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