{"type":"trials","record":{"id":41944,"source_id":"clinicaltrials-gov","external_id":"NCT06582511","title":"Evaluating Metabolic Changes Induced by PhotoBioModulation Through Spectrally Resolved Autofluorescence in Dry Age-Related Macular Degeneration Patients","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.","overall_status":"Unknown","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Francesco Bandello","enrollment":30,"countries":["Italy"],"start_date":"2022-07-11","completion_date":"2025-12-31","last_update_date":"2024-09-03","source_url":"https://clinicaltrials.gov/study/NCT06582511","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"PBM-dAMD","age_range":"50 Years","comparator":null,"organization":"IRCCS Ospedale San Raffaele","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT) — form baseline to month 6","The change in SrAF To evaluate the modification of SrAF stimulated by the PBM treatment — from baseline until month 6","Evaluation of changes in Best Corrected Visual Acuity (ETDRS) — form baseline to month 6","Evaluation of changes in contrast sensitivity — form baseline to month 6","evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Dom…","evaluation of changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS…","evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic…"],"design_description":null,"source_has_results":false},"controlled_terms":["Macular Degeneration, Age Related"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06582511","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-07-11 to 2025-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.896Z","intervention":[],"participants":30,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["changes in blue autofluorescence using Spectral Domain Optical Coherence Tomography (SD-OCT) — form baseline to month 6","The change in SrAF To evaluate the modification of SrAF stimulated by the PBM treatment — from baseline until month 6","Evaluation of changes in Best Corrected Visual Acuity (ETDRS) — form baseline to month 6","Evaluation of changes in contrast sensitivity — form baseline to month 6","evaluation of drusen volume, central drusen thickness, retinal volume, and central retinal thickness using Spectral Dom…","evaluation of changes in choriocapillary perfusion density on Swept Source Optical Coherence Tomography Angiography (SS…","evaluation of changes in retinal sensitivity on microperimetry and the rate of progression to advanced AMD (geographic…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41944","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}