Clinical Research Directory
Browse clinical research sites, groups, and studies.
Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration
Sponsor: Fondazione G.B. Bietti, IRCCS
Summary
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.
Official title: Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2026-06-01
Completion Date
2027-12-31
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
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 and pulsed modes. The treatment is non-invasive and does not produce thermal damage, aiming to stimulate mitochondrial activity, reduce oxidative stress, and modulate inflammatory pathways in retinal cells.
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 photobiomodulation therapy.
Locations (1)
IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico
Roma, Italy, Italy