Macular Degeneration, Age RelatedPBM-dAMDNCT06582511
Evaluating Metabolic Changes Induced by PhotoBioModulation Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration Patients
An observational study of Macular Degeneration, Age Related, run by Francesco Bandello at 1 site in Italy.
Trial summary
The best treatment to prevent the evolution of early and intermediate forms of dAMD to atrophic degeneration is PhotoBioModulation (PBM). It is based on the principle that molecules can absorb light even if it is not part of specialized light-receiving organs. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Age Related
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Up to 30 subjects will be enrolled from October 2021 to December 2023. The follow-up will last 6 months. Following the diagnosis of dAMD, the patient will be referred for photobiomodulation treatment. On the occasion of this visit, the patient will be offered to participate in the study. After providing informed consent and documenting it in writing, subjects will be screened.. Screening evaluations may be performed at any time within the 14 days preceding and subjects must fulfill the following criteria
Who may be able to join
- Male or female at least 50 years;
- Subjects with ETDRS BCVA letter scores of between 50 and 80 (Snellen equivalent of 20/100 to 20/25);
- Subjects with a diagnosis of dry AMD as defined by the presence of drusen (regular or reticular pseudodrusen) and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or Heidelberg FAF;
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study; The subject is informed of the nature of this study and has provided written informed consent in accordance with institutional, local, and national regulatory guidelines.
Who cannot join
- Pregnant or lactating women
- Current or history of neovascular maculopathy that includes any of the following:
- Macular neovascularization (MNV) is defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
- Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
- Retinal hard exudates
- Subretinal and sub-RPE fibrovascular proliferation
Show all 23Show fewer
- Disciform scar
- Presence of center involving GA within the central ETDRS 500 μm diameter at diagnosis
- Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 24 months
- Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 24 months
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months before treatment
- Ocular disorder or disease that partially or completely obstructs the pupil (e.g., posterior synechia in uveitis)
- A visually significant disease in any ocular structure apart from dry AMD (e.g., diabetic macular edema, glaucoma (using >2 eye drops medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases)
- Has a serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgment of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
- Presence of or history of malignancy within the past 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in situ
- Is non-ambulatory
- Presence or history of known light sensitivity to yellow light, red light, or near-infrared radiation (NIR), or if there is a history of light-activated CNS disorders (e.g., epilepsy, migraine)
- Use of any photosensitizing agent (e.g., topical, injectable) within 30 days of treatment without consulting the subject's physician
- History of drug, alcohol, or substance abuse within 3 months before treatment
- Has received an investigational drug or treatment with an investigational device within 3 months before treatment
- If on any antioxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month before Screening. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor.
- Has received Low Vision Rehab/Therapy within 30 days before Screening or intends to receive during the study
- In the opinion of the Investigator, is unlikely to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Metabolic Changes Induced by PhotoBioModulation (PBM) Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration (dAMD) Patients
The best treatment to prevent the evolution of early and intermediate forms of dAMD to atrophic degeneration is PhotoBioModulation (PBM). It is based on the principle that molecules can absorb light even if it is not part of specialized light-receiving organs. Irradiation of cells at certain wavelengths can be used to activate native molecules to modulate biochemical reactions and, consequently, whole cellular metabolism. One of the main targets of PBM is mitochondrial activity. Mitochondria are sensitive to irradiation with red-NIR light. PBM might also function by increasing the bioavailability of nitric oxide (NO) by prompting its release from intracellular stores. It is proposed that PBM causes the photodissociation NO from CCO15. NO is known to inhibit electron transport, so dissociation of NO can increase the mitochondrial membrane potential, increase O2, consumption, and thus the proton gradient, ultimately leading to an increase in ATP production. NO can also diffuse outside and act as a messenger capable of causing vasodilation and other effects.
PBM demonstrated a beneficial role in dAMD, characterized by mitochondrial dysfunction, oxidative stress, and inflammation. SrAF allows to assess of mitochondrial function, a target of PBM, as it allows the observation of minor fluorophores such as FAD. The SrAF is used to evaluate the effectiveness of the treatment.
Read the detailed description
This study is an observational, prospective, longitudinal, and monocentric study on Medical Device (CE marked, according to indications for use) on evaluating metabolic changes through Spectrally Resolved Autofluorescence in subjects with dry AMD.
Subjects will receive PBM treatments, as clinical practice, to stimulate metabolic mitochondrial activity which will be evaluated through Spectrally Resolved Autofluorescence.
Up to 30 subjects will be enrolled. The follow-up will last 6 months. Following the diagnosis of dAMD, the patient will be referred for photobiomodulation treatment.
Efficacy assessments will include slit lamp and fundus examinations, Intraocular pressure (IOP), ETDRS BCVA, CS, BAF, SR-AF, SD-OCT, Swept Source OCT-Angiography (SS-OCTA), and microperimetry. Whenever possible, the same person should perform the evaluations specified by the protocol at each study visit. Unless otherwise indicated, all ocular assessments should be performed on the study eye only.
Safety assessments include incidence of adverse events/serious adverse events, visual acuity, slit lamp findings, crystalline lens changes in phakic eyes, intraocular pressure, and fundus findings. The reporting period is from day 0 through the last study visit (Month 12).
The Primary Objective is to evaluate the modification of SrAF stimulated by the PBM treatment. The secondary objective is to evaluate the effectiveness of PBM treatment.
- Conditions
- Macular Degeneration, Age Related
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT)
changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT
Measured: form baseline to month 6
The change in SrAF To evaluate the modification of SrAF stimulated by the PBM treatment
evaluation of the changes in SrAF measurements
Measured: from baseline until month 6
Secondary outcomes (5)
Evaluation of changes in Best Corrected Visual Acuity (ETDRS)
Evaluation of changes in Best Corrected Visual Acuity (ETDRS)
Measured: form baseline to month 6
Evaluation of changes in contrast sensitivity
Evaluation of changes in contrast sensitivity
Measured: form baseline to month 6
evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Domain Optical Coherence Tomography (SD-OCT)
evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Domain Optical Coherence Tomography (SD-OCT)
Measured: form baseline to month 6
evaluation of changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS-OCTA)
evaluation of changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS-OCTA)
Measured: form baseline to month 6
evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic atrophy)
evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic atrophy)
Measured: form baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start11 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Age RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesco Bandello
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Bandello, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582511
- Sponsor's protocol ID
- PBM-dAMD
- Acronym
- PBM-dAMD
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Metabolic Changes Induced by PhotoBioModulation (PBM) Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration (dAMD) Patients
- ClinicalTrials.gov ID
- NCT06582511
- Acronym / sponsor ID
- PBM-dAMD / PBM-dAMD
- Conditions
- Macular Degeneration, Age Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Francesco BandelloUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Sep 2024 (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.
The best treatment to prevent the evolution of early and intermediate forms of dAMD to atrophic degeneration is PhotoBioModulation (PBM). It is based on the principle that molecules can absorb light even if it is not part of specialized light-receiving organs. Irradiation of cells at certain wavelengths can be used to activate native molecules to modulate biochemical reactions and, consequently, whole cellular metabolism. One of the main targets of PBM is mitochondrial activity. Mitochondria are sensitive to irradiation with red-NIR light. PBM might also function by increasing the bioavailability of nitric oxide (NO) by prompting its release from intracellular stores. It is proposed that PBM causes the photodissociation NO from CCO15. NO is known to inhibit electron transport, so dissociation of NO can increase the mitochondrial membrane potential, increase O2, consumption, and thus the proton gradient, ultimately leading to an increase in ATP production. NO can also diffuse outside and act as a messenger capable of causing vasodilation and other effects.
PBM demonstrated a beneficial role in dAMD, characterized by mitochondrial dysfunction, oxidative stress, and inflammation. SrAF allows to assess of mitochondrial function, a target of PBM, as it allows the observation of minor fluorophores such as FAD. The SrAF is used to evaluate the effectiveness of the treatment.
Detailed description
This study is an observational, prospective, longitudinal, and monocentric study on Medical Device (CE marked, according to indications for use) on evaluating metabolic changes through Spectrally Resolved Autofluorescence in subjects with dry AMD.
Subjects will receive PBM treatments, as clinical practice, to stimulate metabolic mitochondrial activity which will be evaluated through Spectrally Resolved Autofluorescence.
Up to 30 subjects will be enrolled. The follow-up will last 6 months. Following the diagnosis of dAMD, the patient will be referred for photobiomodulation treatment.
Efficacy assessments will include slit lamp and fundus examinations, Intraocular pressure (IOP), ETDRS BCVA, CS, BAF, SR-AF, SD-OCT, Swept Source OCT-Angiography (SS-OCTA), and microperimetry. Whenever possible, the same person should perform the evaluations specified by the protocol at each study visit. Unless otherwise indicated, all ocular assessments should be performed on the study eye only.
Safety assessments include incidence of adverse events/serious adverse events, visual acuity, slit lamp findings, crystalline lens changes in phakic eyes, intraocular pressure, and fundus findings. The reporting period is from day 0 through the last study visit (Month 12).
The Primary Objective is to evaluate the modification of SrAF stimulated by the PBM treatment. The secondary objective is to evaluate the effectiveness of PBM treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 30 subjects will be enrolled from October 2021 to December 2023. The follow-up will last 6 months. Following the diagnosis of dAMD, the patient will be referred for photobiomodulation treatment. On the occasion of this visit, the patient will be offered to participate in the study. After providing informed consent and documenting it in writing, subjects will be screened.. Screening evaluations may be performed at any time within the 14 days preceding and subjects must fulfill the following criteria
Key inclusion criteria (4 listed)
- Male or female at least 50 years;
- Subjects with ETDRS BCVA letter scores of between 50 and 80 (Snellen equivalent of 20/100 to 20/25);
- Subjects with a diagnosis of dry AMD as defined by the presence of drusen (regular or reticular pseudodrusen) and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or Heidelberg FAF;
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study; The subject is informed of the nature of this study and has provided written informed consent in accordance with institutional, local, and national regulatory guidelines.
Key exclusion criteria (23 listed)
- Pregnant or lactating women
- Current or history of neovascular maculopathy that includes any of the following:
- Presence of center involving GA within the central ETDRS 500 μm diameter at diagnosis
- Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 24 months
- Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: form baseline to month 6
changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT
The change in SrAF To evaluate the modification of SrAF stimulated by the PBM treatment
Time frame: from baseline until month 6
evaluation of the changes in SrAF measurements
5 secondary outcomes
Evaluation of changes in Best Corrected Visual Acuity (ETDRS)
Time frame: form baseline to month 6
Evaluation of changes in contrast sensitivity
Time frame: form baseline to month 6
evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: form baseline to month 6
evaluation of changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS-OCTA)
Time frame: form baseline to month 6
evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic atrophy)
Time frame: form baseline to month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, Age Related, run by Francesco Bandello 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 4 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT) (time frame: form baseline to month 6). The study lists 2 primary outcomes in all. 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 3 Sep 2024.