Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582511
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Evaluating Metabolic Changes Induced by PhotoBioModulation Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Metabolic Changes Induced by PhotoBioModulation PBM Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration dAMD Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBM-dAMD
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
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 eventsserious 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
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 eventsserious 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None