AMD - Age-Related Macular DegenerationPBM in iAMDNCT07554690
Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration
A study testing Photobiomodulation Therapy in people with AMD - Age-Related Macular Degeneration, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD - Age-Related Macular Degeneration
- What is being tested?
- Photobiomodulation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eliana Costanzo, MD contact
Italy1 site
IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico
Roma, Italy, 00184
Mariacristina Parravano, Prof., +390684009442, mariacristina.parravano@fondazionebietti.it
About this study
Official title: Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
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.
Read the 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.
- Conditions
- AMD - Age-Related Macular Degeneration
- Being tested
- Photobiomodulation Therapy, Sham Photobiomodulation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyProcedure or surgery
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.
Sham PhotobiomodulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 12
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD - Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554690
- Sponsor's protocol ID
- RET 04-26
- Acronym
- PBM in iAMD
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07554690
- Acronym / sponsor ID
- PBM in iAMD / RET 04-26
- Conditions
- AMD - Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) Laser Treatment | Experimental | Procedure: Photobiomodulation TherapyParticipants 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. |
| Sham Treatment | Placebo comparator | Procedure: Sham PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation TherapyPhotobiomodulation (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. | Procedure or surgery | Photobiomodulation (PBM) Laser Treatment |
| Sham PhotobiomodulationThe 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. | Procedure or surgery | Sham Treatment |
Primary outcome
Change in Low-Luminance Visual Acuity (LLVA)
Time frame: 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.
9 secondary outcomes
Change in Low-Luminance Contrast Sensitivity (LLCS)
Time frame: Baseline to Month 12
Change in Retinal Sensitivity Measured by Microperimetry
Time frame: Baseline to Month 12
Change in Retinal Structure Assessed by Optical Coherence Tomography (SD-OCT)
Time frame: Baseline to Month 12
Change in Fundus Autofluorescence Patterns
Time frame: Baseline to Month 12
Progression to Advanced Age-Related Macular Degeneration
Time frame: Up to Month 12
Change in Retinal Perfusion Density Assessed by OCT Angiography
Time frame: Baseline to Month 12
Change in Vessel Length Density Assessed by OCT Angiography
Time frame: Baseline to Month 12
Change in Foveal Avascular Zone Area Assessed by OCT Angiography
Time frame: Baseline to Month 12
Change in Choriocapillaris Flow Deficit Assessed by OCT Angiography
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliana Costanzo, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy in people with AMD - Age-Related Macular Degeneration, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariacristina Parravano, Prof. (+390684009442, cristinaparravano@fondazionebietti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low-Luminance Visual Acuity (LLVA) (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.