{"type":"trials","record":{"id":42012,"source_id":"clinicaltrials-gov","external_id":"NCT04884399","title":"Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD","brief_summary":"This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis® in patients with wet age-related macular degeneration.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Shanghai Biomabs Pharmaceutical Co., Ltd.","enrollment":24,"countries":["China"],"start_date":"2021-06-03","completion_date":"2022-12-22","last_update_date":"2024-03-28","source_url":"https://clinicaltrials.gov/study/NCT04884399","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 to 80 Years","comparator":"Lucentis®","organization":"Shanghai Biomabs Pharmaceutical Co., Ltd.","interventions":["CMAB818","Lucentis®"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of Participants With Adverse Events That Are Related to Treatment — 0~42 days","Number of Participants With anti-drug antibody — 0~42 days","Percentage of neutralizing antibody — 0~42 days","AUC(0-t) — 0~42 days","Cmax — 0~42 days","CL — 0~42 days","Half-life (t1/2) — 0~42 days","Pharmacodynamics — 0~42 days","Mean change in best corrected visual acuity (BCVA) from baseline — 0~42 days","Mean change in central retinal thickness from baseline — 0~42 days","Mean change in lesion area from baseline — 0~42 days","Mean change in leakage area from baseline — 0~42 days"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Wet Age-related Macular Degeneration","CMAB818","Lucentis®"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct04884399","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-06-03 to 2022-12-22","comparator":"Lucentis®","confidence":"structured-source","population":"ALL · 50 Years to 80 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":"2026-09-25T06:20:47.907Z","intervention":["CMAB818","Lucentis®"],"participants":24,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Number of Participants With Adverse Events That Are Related to Treatment — 0~42 days","Number of Participants With anti-drug antibody — 0~42 days","Percentage of neutralizing antibody — 0~42 days","AUC(0-t) — 0~42 days","Cmax — 0~42 days","CL — 0~42 days","Half-life (t1/2) — 0~42 days","Pharmacodynamics — 0~42 days","Mean change in best corrected visual acuity (BCVA) from baseline — 0~42 days","Mean change in central retinal thickness from baseline — 0~42 days","Mean change in lesion area from baseline — 0~42 days","Mean change in leakage area from baseline — 0~42 days"],"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/42012","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}