{"type":"trials","record":{"id":42128,"source_id":"clinicaltrials-gov","external_id":"NCT01756248","title":"EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan","brief_summary":"This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD). The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice. A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Bayer","enrollment":3872,"countries":["Japan"],"start_date":"2012-12-26","completion_date":"2019-05-20","last_update_date":"2023-06-07","source_url":"https://clinicaltrials.gov/study/NCT01756248","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":null,"comparator":null,"organization":"Bayer","interventions":["Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of E…","Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV inj…","Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulation…","Mean changes in visual acuity — Baseline and 6, 24 or 36 months","Proportion of patients who maintained visual acuity(corresponding to 0 letter of ETDRS from baseline) — Up to 3 years","Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments —…","Number and intervals of ITV injection of EYLEA — Up to 3 years"],"design_description":null,"source_has_results":false},"controlled_terms":["Macular Degeneration","Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct01756248","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2012-12-26 to 2019-05-20","comparator":null,"confidence":"structured-source","population":"ALL","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":"2026-09-25T06:20:47.924Z","intervention":["Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)"],"participants":3872,"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":["Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of E…","Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV inj…","Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulation…","Mean changes in visual acuity — Baseline and 6, 24 or 36 months","Proportion of patients who maintained visual acuity(corresponding to 0 letter of ETDRS from baseline) — Up to 3 years","Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments —…","Number and intervals of ITV injection of EYLEA — Up to 3 years"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","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/42128","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}