Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration

NCT07554690 | Not Yet Recruiting

• 1 other identifier: RET 04-26
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

AMD - Age-Related Macular Degeneration

Outcome Measures

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.

  Baseline to Month 12

Secondary Outcomes (9)

• Change in Low-Luminance Contrast Sensitivity (LLCS)

  Baseline to Month 12

• Change in Retinal Sensitivity Measured by Microperimetry

  Baseline to Month 12

• Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT)

  Baseline to Month 12

• Change in Fundus Autofluorescence Patterns

  Baseline to Month 12

• Progression to Advanced Age-Related Macular Degeneration

  Up to Month 12

Study Arms (2)

Photobiomodulation (PBM) Laser Treatment

EXPERIMENTAL

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

Sham Treatment

PLACEBO COMPARATOR

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

Interventions

Photobiomodulation Therapy PROCEDURE

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.

Photobiomodulation (PBM) Laser Treatment

Sham Photobiomodulation PROCEDURE

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.

Sham Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico

Roma, Italy, 00184, Italy

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Mariacristina Parravano, Prof.

CONTACT

+390684009442; cristinaparravano@fondazionebietti.it

Eliana Costanzo, MD

CONTACT

eliana.costanzo@fondazionebietti.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IT (1)