{"type":"trials","record":{"id":41837,"source_id":"clinicaltrials-gov","external_id":"NCT04847635","title":"Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration","brief_summary":"Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Ospedale San Raffaele","enrollment":50,"countries":["Italy"],"start_date":"2021-03-16","completion_date":"2026-09-01","last_update_date":"2025-03-12","source_url":"https://clinicaltrials.gov/study/NCT04847635","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: 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":"PASCAL-RPD","age_range":"55 Years","comparator":null,"organization":"Ospedale San Raffaele","interventions":["Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)","Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Changes in the retinal sensitivity - 12 months — 12 months","Anatomical changes using structural optical coherence tomography (OCT) — 12 months","Rate of Progression — 12 months","Changes in the retinal sensitivity - 6 months — 6 months","Anatomical changes using fundus autofluorescence (FAF) — 12 months","Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients) — 12 months","Anatomical changes using OCT-angiography (OCT-A) — 12 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Macular Degeneration, Senile","Laser Burn of Retina","Macular Degeneration Intermediate","Macular Degeneration, Dry","Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)","Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)"],"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:nct04847635","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-03-16 to 2026-09-01","comparator":null,"confidence":"structured-source","population":"ALL · 55 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":"2026-09-25T06:20:47.879Z","intervention":["Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)","Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)"],"participants":50,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","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 the retinal sensitivity - 12 months — 12 months","Anatomical changes using structural optical coherence tomography (OCT) — 12 months","Rate of Progression — 12 months","Changes in the retinal sensitivity - 6 months — 6 months","Anatomical changes using fundus autofluorescence (FAF) — 12 months","Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients) — 12 months","Anatomical changes using OCT-angiography (OCT-A) — 12 months"],"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 INTERVENTIONAL."],"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/41837","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}