{"type":"trials","record":{"id":41614,"source_id":"clinicaltrials-gov","external_id":"NCT07409389","title":"Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration","brief_summary":"This prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in patients with dry age-related macular degeneration (AMD). The primary objective is to assess the effect of RLRL therapy on visual function in patients with dry AMD, while the secondary objective is to evaluate its safety and tolerability. Seventy-four participants aged 50 years or older with dry AMD will be enrolled and randomly assigned in a 1:1 ratio to either the active RLRL intervention group (using the full device power) or the control group (sham device at 10% power). Group assignments will be masked to both participants and investigators. Participants will administer the treatment at home twice daily (3-minute sessions, with at least a 4-hour interval between sessions) over five consecutive weekdays each month for three months. A video tutorial will guide device usage, with ongoing support from the research team. Before enrollment, participants will undergo a comprehensive assessment, including ocular and family history review, OCT, and fundus photography to confirm eligibility. Evaluations will occur at baseline, 1 month, and 3 months, covering best-corrected visual acuity (BCVA), slit-lamp examination, OCT, OCT angiography (OCTA), fundus autofluorescence (FAF), contrast sensitivity, color vision, electroretinography (ERG), visual-related quality of life (VRQL) questionnaires, and adverse event monitoring. The primary outcome is the mean change in BCVA from baseline to 3 months. Secondary outcomes include changes in central drusen thickness, geographic atrophy (GA) size and progression, choroidal blood flow, contrast sensitivity, ERG responses, and VRQL scores. Given the limited treatment options for dry AMD, which are primarily focused on lifestyle changes and nutritional supplements, this study investigates the potential of RLRL therapy as a novel, non-invasive treatment. The results may address the unmet medical need in dry AMD, potentially slowing disease progression and improving patients' quality of life.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"The Hong Kong Polytechnic University","enrollment":94,"countries":["China"],"start_date":"2026-01-26","completion_date":"2026-12-01","last_update_date":"2026-02-13","source_url":"https://clinicaltrials.gov/study/NCT07409389","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. 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":null,"age_range":"50 Years","comparator":"RLRL therapy group","organization":"The Hong Kong Polytechnic University","interventions":["RLRL device","Sham device"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The mean change in BCVA measured by ETDRS chart — At 1month and 3 months compared to baseline","Change in central drusen volume measured by optical coherence tomography (OCT) — At 1month and 3 months compared to bas…","Change in central drusen thickness measured by optical coherence tomography (OCT). — At 1month and 3 months compared to…","Change in retinal sensitivity using microperimetry. — At 1month and 3 months compared to baseline","Outcomes of visual-related quality of life (VRQL) assessed by the 25-item National Eye Institute Visual Function Questi…","Size of GA assessed by fundus autofluorescence (FAF) imaging — At 1month and 3 months compared to baseline","Change in contrast sensitivity using the Mars Letter Contrast Sensitivity Test — At 1month and 3 months compared to bas…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["AMD - Age-Related Macular Degeneration","RLRL device","Sham device"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct07409389","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-01-26 to 2026-12-01","comparator":"RLRL therapy group","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":"2026-09-25T06:20:47.841Z","intervention":["RLRL device","Sham device"],"participants":94,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["The mean change in BCVA measured by ETDRS chart — At 1month and 3 months compared to baseline","Change in central drusen volume measured by optical coherence tomography (OCT) — At 1month and 3 months compared to bas…","Change in central drusen thickness measured by optical coherence tomography (OCT). — At 1month and 3 months compared to…","Change in retinal sensitivity using microperimetry. — At 1month and 3 months compared to baseline","Outcomes of visual-related quality of life (VRQL) assessed by the 25-item National Eye Institute Visual Function Questi…","Size of GA assessed by fundus autofluorescence (FAF) imaging — At 1month and 3 months compared to baseline","Change in contrast sensitivity using the Mars Letter Contrast Sensitivity Test — At 1month and 3 months compared to bas…"],"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.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"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/41614","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}