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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Photobiomodulation Therapy
Procedure/SurgeryPhotobiomodulation (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
Procedure/SurgeryThe 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.
Treatment groups
67 Participants
are divided into 2 treatment groupsGroup A: Photobiomodulation (PBM) Laser TreatmentExperimental treatment 1 intervention
Group B: Sham TreatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Low-Luminance Visual Acuity (LLVA)
Low-luminance visual acuity (LLVA) will be assessed as the change from baseline to Month 12, measured using standardized ETDRS charts under low-luminance conditions. The analysis will compare the mean change between the photobiomodulation treatment group and the sham control group.
Time frame
Baseline to Month 12Secondary outcomes
1
Change in Low-Luminance Contrast Sensitivity (LLCS)
Low-luminance contrast sensitivity (LLCS) will be assessed as the change from baseline to Month 12 using standardized contrast sensitivity charts. Differences between the photobiomodulation and sham groups will be evaluated.
Time frame
Baseline to Month 122
Change in Retinal Sensitivity Measured by Microperimetry
Retinal sensitivity will be evaluated as the change from baseline to Month 12 using microperimetry. Mean sensitivity values will be compared between the treatment and control groups.
Time frame
Baseline to Month 123
Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT)
Structural retinal changes will be assessed as the change from baseline to Month 12 using spectral-domain optical coherence tomography (SD-OCT), including macular thickness measurements.
Time frame
Baseline to Month 124
Change in Fundus Autofluorescence Patterns
Changes in fundus autofluorescence patterns will be assessed from baseline to Month 12 to evaluate alterations in retinal pigment epithelium.
Time frame
Baseline to Month 12Sponsors and contacts
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Source ClinicalTrials.gov
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