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Low-energy laser light treatment for reticular pseudodrusen in age-related macular degeneration

Tests a low-energy laser against a sham treatment in people with early macular degeneration.

Plain-language title generated from the registry record
Registry title: Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration

Key facts

Where
Roma, ItalySee the site

Where in Italy

  • IRCCS Fondazione G.B.Bietti c/o Ospedale BritannicoRoma, ItalyNo longer taking part

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Trial details

Who runs it
Fondazione G.B. Bietti, IRCCS
Trial code
NCT07554690
Record updated
4 September 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Any previous treatment for age-related macular degeneration, except for antioxidant supplementation; Use of phototoxic medications (including certain antibiotics or chemotherapeutics) during PBM treatment; 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; Previous therapeutic radiation to the ocular region or face; History of uveitis (idiopathic or autoimmune); History of vitrectomy, filtering surgery, corneal transplantation, or retinal detachment in the study eye; Presence of geographic atrophy; Evidence of macular neovascularization; Media opacities that may interfere with retinal imaging assessments; Any ocular or systemic treatment known to be toxic to the retina or optic nerve; Neovascular glaucoma; Glaucoma due to congenital anomalies; Glaucoma secondary to active uveitis; Women of childbearing potential not using effective contraception during the study treatment period.

ClinicalTrials.gov NCT07554690