AMD - Age-Related Macular Degeneration
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREPhotobiomodulation 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.
PROCEDURESham 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.
Sponsors
Fondazione G.B. Bietti, IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low-Luminance Visual Acuity (LLVA) | Baseline to Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low-Luminance Contrast Sensitivity (LLCS) | Baseline to Month 12 | 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. |
| Change in Retinal Sensitivity Measured by Microperimetry | Baseline to Month 12 | 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. |
| Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT) | Baseline to Month 12 | 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. |
| Change in Fundus Autofluorescence Patterns | Baseline to Month 12 | Changes in fundus autofluorescence patterns will be assessed from baseline to Month 12 to evaluate alterations in retinal pigment epithelium. |
| Progression to Advanced Age-Related Macular Degeneration | Up to Month 12 | The proportion of participants progressing to advanced forms of age-related macular degeneration will be assessed over the 12-month follow-up period. |
| Change in Retinal Perfusion Density Assessed by OCT Angiography | Baseline to Month 12 | Retinal perfusion density will be assessed as the change from baseline to Month 12 using OCT angiography. |
| Change in Vessel Length Density Assessed by OCT Angiography | Baseline to Month 12 | Vessel length density will be assessed as the change from baseline to Month 12 using OCT angiography. |
| Change in Foveal Avascular Zone Area Assessed by OCT Angiography | Baseline to Month 12 | Foveal avascular zone area will be assessed as the change from baseline to Month 12 using OCT angiography. |
| Change in Choriocapillaris Flow Deficit Assessed by OCT Angiography | Baseline to Month 12 | Choriocapillaris flow deficit will be assessed as the change from baseline to Month 12 using OCT angiography. |
Countries
Italy
Contacts
CONTACTMariacristina Parravano, Prof.
CONTACTEliana Costanzo, MD
Outcome results
None listed