An interventional study of Photobiomodulation Therapy and Sham Photobiomodulation in AMD - Age-Related Macular Degeneration, sponsored by Fondazione G.B. Bietti, IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Fondazione G.B. Bietti, IRCCS · Not applicable, Interventional, and Treatment
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.
This is a prospective, randomized, single-center interventional clinical study designed to evaluate the efficacy of photobiomodulation (PBM) laser therapy in patients with reticular pseudodrusen associated with intermediate age-related macular degeneration (AMD).
PBM is a non-invasive treatment that uses low-energy light to modulate cellular activity, improve mitochondrial function, and reduce oxidative stress and inflammation, which are key mechanisms involved in AMD progression. Although previous studies have shown promising results, evidence remains heterogeneous and further investigation is needed, particularly regarding functional outcomes.
Participants will be randomly assigned in a 2:1 ratio to receive either active PBM treatment or sham treatment. The intervention consists of two treatment cycles delivered over several weeks, using a CE-marked medical device. Each session includes exposure to specific wavelengths of light under standardized conditions.
The study focuses on both functional and structural outcomes. Functional assessments include low-luminance visual acuity, contrast sensitivity, and microperimetry, while structural changes are evaluated using multimodal retinal imaging techniques such as spectral-domain optical coherence tomography, fundus autofluorescence, and OCT angiography.
Participants will be followed for 12 months to assess changes from baseline and compare outcomes between the treatment and control groups. The study aims to determine whether PBM therapy can improve visual function and potentially slow disease progression in patients with early stages of AMD.
Exclusion Criteria:
Participants assigned to this arm will receive photobiomodulation (PBM) therapy using a CE-marked medical device. Treatment is delivered in two cycles: the first cycle consists of 8 sessions over 4 weeks (two sessions per week), and the second cycle consists of 6 sessions over 3 weeks. Each session lasts approximately 12 minutes and includes exposure to specific wavelengths of light under standardized conditions.
Procedure: Photobiomodulation Therapy
Participants assigned to this arm will undergo sham treatment following the same schedule and procedures as the active treatment group, including identical session frequency and duration. The device delivers minimal, non-therapeutic light energy, ensuring no active photobiomodulation effect while maintaining masking conditions.
Procedure: Sham Photobiomodulation
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.
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.
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 12
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 12
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 12
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 12
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 12
Progression to Advanced Age-Related Macular Degeneration
The proportion of participants progressing to advanced forms of age-related macular degeneration will be assessed over the 12-month follow-up period.
Time frame: Up to Month 12
Change in Retinal Perfusion Density Assessed by OCT Angiography
Retinal perfusion density will be assessed as the change from baseline to Month 12 using OCT angiography.
Time frame: Baseline to Month 12
Change in Vessel Length Density Assessed by OCT Angiography
Vessel length density will be assessed as the change from baseline to Month 12 using OCT angiography.
Time frame: Baseline to Month 12
Change in Foveal Avascular Zone Area Assessed by OCT Angiography
Foveal avascular zone area will be assessed as the change from baseline to Month 12 using OCT angiography.
Time frame: Baseline to Month 12
Change in Choriocapillaris Flow Deficit Assessed by OCT Angiography
Choriocapillaris flow deficit will be assessed as the change from baseline to Month 12 using OCT angiography.
Time frame: Baseline to Month 12
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fondazione G.B. Bietti, IRCCS