Evaluating Metabolic Changes Induced by PhotoBioModulation Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration Patients
- Conditions
- Macular Degeneration, Age Related
- Registration Number
- NCT06582511
- Lead Sponsor
- Francesco Bandello
- Brief 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. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT) 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 from baseline until month 6 evaluation of the changes in SrAF measurements
- Secondary Outcome Measures
Name Time Method Evaluation of changes in Best Corrected Visual Acuity (ETDRS) form baseline to month 6 Evaluation of changes in Best Corrected Visual Acuity (ETDRS)
Evaluation of changes in contrast sensitivity form baseline to month 6 Evaluation of changes in contrast sensitivity
evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Domain Optical Coherence Tomography (SD-OCT) 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 changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS-OCTA) 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 retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic atrophy) form baseline to month 6 evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic atrophy)