Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorFondazione G.B. Bietti, IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Photobiomodulation Therapy
- Sham Photobiomodulation
Treatment groups
67 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov