{"type":"trials","record":{"id":42105,"source_id":"clinicaltrials-gov","external_id":"NCT05251636","title":"Adjunct Episcleral Brachytherapy for PCV","brief_summary":"This study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.","overall_status":"Not Yet Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Salutaris Medical Devices, Inc.","enrollment":159,"countries":[],"start_date":"2025-03-01","completion_date":"2028-09-01","last_update_date":"2023-08-30","source_url":"https://clinicaltrials.gov/study/NCT05251636","editorial_summary":"A registered PHASE3 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":"KILAUEA","age_range":"50 Years","comparator":"IAI monotherapy","organization":"Salutaris Medical Devices, Inc.","interventions":["Episcleral Brachytherapy","Aflibercept Injection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Best Corrected Visual Acuity (BCVA) — 12 months","Best Corrected Visual Acuity (BCVA) — 24 months","Central Retinal Thickness — 12 and 24 months","Lesion size — 12 and 24 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Polypoid Choroidal Vasculopathy","Episcleral Brachytherapy","Aflibercept Injection"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05251636","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-03-01 to 2028-09-01","comparator":"IAI monotherapy","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":"2026-09-25T06:20:47.920Z","intervention":["Episcleral Brachytherapy","Aflibercept Injection"],"participants":159,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Best Corrected Visual Acuity (BCVA) — 12 months","Best Corrected Visual Acuity (BCVA) — 24 months","Central Retinal Thickness — 12 and 24 months","Lesion size — 12 and 24 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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/42105","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}