{"type":"trials","record":{"id":41801,"source_id":"clinicaltrials-gov","external_id":"NCT03814291","title":"A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration","brief_summary":"This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","enrollment":31,"countries":["China"],"start_date":"2019-04-15","completion_date":"2020-04-10","last_update_date":"2025-04-17","source_url":"https://clinicaltrials.gov/study/NCT03814291","editorial_summary":"A registered PHASE1 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":"50 Years","comparator":null,"organization":"Innovent Biologics (Suzhou) Co. Ltd.","interventions":["IBI302"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Safety evaluation indicators — Baseline to Day43","Efficacy evaluation indicators — Baseline to Day43","Immunogenicity evaluation indicators — Baseline to Day43","The area under the drug-time curve from 0 to time t (AUC0-t) — Baseline to Day43","The area under the curve at the time of 0-infinity (AUC0-∞) — Baseline to Day43","The peak concentration (Cmax) — Baseline to Day43","The peak time (Tmax) — Baseline to Day43","Clearance rate (CL) — Baseline to Day43","Half-life (t1/2) — Baseline to Day43","Free and total VEGF concentration — Baseline to Day43"],"design_description":"NON RANDOMIZED · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","IBI302"],"relevance_confidence":100,"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:nct03814291","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-04-15 to 2020-04-10","comparator":null,"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":"2026-09-25T06:20:47.873Z","intervention":["IBI302"],"participants":31,"study_design":"NON RANDOMIZED · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["Safety evaluation indicators — Baseline to Day43","Efficacy evaluation indicators — Baseline to Day43","Immunogenicity evaluation indicators — Baseline to Day43","The area under the drug-time curve from 0 to time t (AUC0-t) — Baseline to Day43","The area under the curve at the time of 0-infinity (AUC0-∞) — Baseline to Day43","The peak concentration (Cmax) — Baseline to Day43","The peak time (Tmax) — Baseline to Day43","Clearance rate (CL) — Baseline to Day43","Half-life (t1/2) — Baseline to Day43","Free and total VEGF concentration — Baseline to Day43"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","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/41801","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}