{"type":"trials","record":{"id":28300,"source_id":"clinicaltrials-gov","external_id":"NCT05230537","title":"A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration","brief_summary":"The purpose of this study is to assess the effect of Iptacopan to prevent conversion of early or intermediate age-related macular degeneration (AMD) eyes to new incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) or late AMD.","overall_status":"Active Not Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":168,"countries":["United States","China","Puerto Rico","United Kingdom"],"start_date":"2022-02-17","completion_date":"2026-09-30","last_update_date":"2026-09-22","source_url":"https://clinicaltrials.gov/study/NCT05230537","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years to 100 Years","comparator":"Placebo","organization":"Novartis","interventions":["Iptacopan (LNP023)","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Development of new incomplete retinal pigment epithelium & outer retinal atrophy or late age-related macular degenerati…","The incidence of ocular and non-ocular adverse events (AEs) — Baseline/Day 1 through Month 24","Change in Early Treatment Diabetic Retinopathy Study (ETDRS) (Standard Luminance) best corrected visual acuity (BCVA) s…","Change in ETDRS low luminance visual acuity (LLVA) scores in the early/intermediate AMD eye — Baseline/Day 1 through Mo…","Change in contrast sensitivity (CS) scores in the early/intermediate AMD eye — Baseline/Day 1 through Month 24","Change in Standard luminance manifold contrast vision meter contrast sensitivity (MCVM-CS) scores in the early/intermed…","Pharmacokinetics - concentrations of LNP023 related to trough samples — Baseline/Day 1 through Month 24","Change in low luminance manifold contrast vision meter (MCVM) contrast sensitivity scores in the early/intermediate AMD…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Iptacopan (LNP023)","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct05230537","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-02-17 to 2026-09-30","comparator":"Placebo","confidence":"structured-source","population":"ALL · 50 Years to 100 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":"2026-09-25T06:20:47.791Z","intervention":["Iptacopan (LNP023)","Placebo"],"participants":168,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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":["Development of new incomplete retinal pigment epithelium & outer retinal atrophy or late age-related macular degenerati…","The incidence of ocular and non-ocular adverse events (AEs) — Baseline/Day 1 through Month 24","Change in Early Treatment Diabetic Retinopathy Study (ETDRS) (Standard Luminance) best corrected visual acuity (BCVA) s…","Change in ETDRS low luminance visual acuity (LLVA) scores in the early/intermediate AMD eye — Baseline/Day 1 through Mo…","Change in contrast sensitivity (CS) scores in the early/intermediate AMD eye — Baseline/Day 1 through Month 24","Change in Standard luminance manifold contrast vision meter contrast sensitivity (MCVM-CS) scores in the early/intermed…","Pharmacokinetics - concentrations of LNP023 related to trough samples — Baseline/Day 1 through Month 24","Change in low luminance manifold contrast vision meter (MCVM) contrast sensitivity scores in the early/intermediate AMD…"],"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/28300","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}