{"type":"trials","record":{"id":28334,"source_id":"clinicaltrials-gov","external_id":"NCT06970665","title":"A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration","brief_summary":"Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both. This study is for people in Japan of 40 years of age or older, who have geographic atrophy. The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021. During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection. People will be in the study for about 1 year. People will visit their study clinic several times for health checks.","overall_status":"Active Not Recruiting","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Astellas Pharma Inc","enrollment":17,"countries":["Japan"],"start_date":"2025-07-08","completion_date":"2027-06-30","last_update_date":"2026-09-11","source_url":"https://clinicaltrials.gov/study/NCT06970665","editorial_summary":"A registered PHASE4 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":"40 Years","comparator":null,"organization":"Astellas Pharma Inc","interventions":["avacincaptad pegol"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with Treatment Emergent Adverse Events (TEAEs) — Up to 12 Months","Number of participants with Serious TEAEs — Up to 12 Months","Number of participants with intraocular pressure (IOP) abnormalities and/or AEs — Up to 12 months","Number of participants with ophthalmic examination abnormalities and/or AEs — Up to 12 months","Number of participants with laboratory value abnormalities and/or AEs — Up to 12 months","Number of participants with vital signs abnormalities and/or AEs — Up to 12 months","Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs — Up to 12 months","Mean rate of growth (slope) over 12 months — Up to 12 months","Change from baseline in best corrected visual acuity (BCVA) — Baseline and up to 12 months","Change from baseline in low luminance best corrected visual acuity (LL BCVA) — Baseline and up to 12 months","Number of participants with antidrug antibodies (ADA) status — Up to 12 months","Number of participants with neutralizing antibodies (NAb) status for participant with positive ADA — Up to 12 months","PK of ASP3021 in plasma: Concentration — Up to 2 months","Pharmacokinetics (PK) of ASP3021 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) — Up…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Geographic Atrophy","Age-Related Macular Degeneration","avacincaptad pegol"],"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:nct06970665","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-07-08 to 2027-06-30","comparator":null,"confidence":"structured-source","population":"ALL · 40 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":"2026-09-25T06:20:47.798Z","intervention":["avacincaptad pegol"],"participants":17,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","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 Treatment Emergent Adverse Events (TEAEs) — Up to 12 Months","Number of participants with Serious TEAEs — Up to 12 Months","Number of participants with intraocular pressure (IOP) abnormalities and/or AEs — Up to 12 months","Number of participants with ophthalmic examination abnormalities and/or AEs — Up to 12 months","Number of participants with laboratory value abnormalities and/or AEs — Up to 12 months","Number of participants with vital signs abnormalities and/or AEs — Up to 12 months","Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs — Up to 12 months","Mean rate of growth (slope) over 12 months — Up to 12 months","Change from baseline in best corrected visual acuity (BCVA) — Baseline and up to 12 months","Change from baseline in low luminance best corrected visual acuity (LL BCVA) — Baseline and up to 12 months","Number of participants with antidrug antibodies (ADA) status — Up to 12 months","Number of participants with neutralizing antibodies (NAb) status for participant with positive ADA — Up to 12 months","PK of ASP3021 in plasma: Concentration — Up to 2 months","Pharmacokinetics (PK) of ASP3021 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) — Up…"],"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/28334","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}