{"type":"trials","record":{"id":42112,"source_id":"clinicaltrials-gov","external_id":"NCT05961007","title":"Evaluation of IBI302 Injection in nAMD or DME","brief_summary":"The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.","overall_status":"Suspended","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","enrollment":234,"countries":["China"],"start_date":"2021-11-18","completion_date":"2024-04-30","last_update_date":"2023-07-27","source_url":"https://clinicaltrials.gov/study/NCT05961007","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Suspended. 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":"18 Years","comparator":"Aflibercept","organization":"Innovent Biologics (Suzhou) Co. Ltd.","interventions":["Intravitreal injection of IBI302(dose 1)","Intravitreal injection of IBI302(dose 2)","Intravitreal injection of IBI302(dose 3)","Intravitreal injection of Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and severity of ocular and non-ocular adverse events. — Up to week 20","DLT in each group — 7 days","Change of BCVA from baseline by visit — through study completion，an average of 20 weeks","Change of CST from baseline by visit — through study completion，an average of 20 weeks","Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax) — through study completion，an ave…","The ADA and neutralizing antibody — through study completion，an average of 20 weeks"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Diabetic Macular Edema","Intravitreal injection of IBI302(dose 1)","Intravitreal injection of IBI302(dose 2)","Intravitreal injection of IBI302(dose 3)","Intravitreal injection of Aflibercept"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05961007","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-11-18 to 2024-04-30","comparator":"Aflibercept","confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.921Z","intervention":["Intravitreal injection of IBI302(dose 1)","Intravitreal injection of IBI302(dose 2)","Intravitreal injection of IBI302(dose 3)","Intravitreal injection of Aflibercept"],"participants":234,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, 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":["Incidence and severity of ocular and non-ocular adverse events. — Up to week 20","DLT in each group — 7 days","Change of BCVA from baseline by visit — through study completion，an average of 20 weeks","Change of CST from baseline by visit — through study completion，an average of 20 weeks","Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax) — through study completion，an ave…","The ADA and neutralizing antibody — through study completion，an average of 20 weeks"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/42112","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}