Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration
Starting soon · Not applicable · Has a placebo group
Conditions studied: AMD - Age-Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT07554690
- Run by
- Fondazione G.B. Bietti, IRCCS
- People needed
- 67
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-04
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico — Roma, Italy, Italy
Full record on ClinicalTrials.gov
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