{"type":"trials","record":{"id":41664,"source_id":"clinicaltrials-gov","external_id":"NCT05439629","title":"Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration","brief_summary":"A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Bio-Thera Solutions","enrollment":488,"countries":["China"],"start_date":"2022-07-07","completion_date":"2025-04-22","last_update_date":"2025-12-08","source_url":"https://clinicaltrials.gov/study/NCT05439629","editorial_summary":"A registered PHASE3 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 85 Years","comparator":"Control group：Lucentis®","organization":"Bio-Thera Solutions","interventions":["BAT5906 injection","Lucentis"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The change in the BCVA value — Week 52","The change in the BCVA value — at weeks 12, 24, 36, and 48","BCVA increased the proportion of subjects with >10, >15, ≥30 words — in the 24th and 52nd weeks","BCVA reduced the proportion of subjects < 10, < 15 words — at weeks 24 and 52","Changes in the thickness of the macular fovea (CRT). — at weeks 12, 24, 36, 48, and 52","Vital signs — Weeks 1 to 52","physical examination — Weeks 1 to 52","Laboratory tests — Weeks 1 to 52","electrocardiogram（ ECG ） — Weeks 1 to 52","Antibiotic antibodies (ADA) — Weeks 1 to 52","Adverse events（AE） — Weeks 1 to 52","Adverse events of particular concern (possible adverse reactions to the eye) — Weeks 1 to 52"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Neovascular (Wet) Age-related Macular Degeneration","BAT5906 injection","Lucentis"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct05439629","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-07-07 to 2025-04-22","comparator":"Control group：Lucentis®","confidence":"structured-source","population":"ALL · 50 Years to 85 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":"2026-09-25T06:20:47.850Z","intervention":["BAT5906 injection","Lucentis"],"participants":488,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["The change in the BCVA value — Week 52","The change in the BCVA value — at weeks 12, 24, 36, and 48","BCVA increased the proportion of subjects with >10, >15, ≥30 words — in the 24th and 52nd weeks","BCVA reduced the proportion of subjects < 10, < 15 words — at weeks 24 and 52","Changes in the thickness of the macular fovea (CRT). — at weeks 12, 24, 36, 48, and 52","Vital signs — Weeks 1 to 52","physical examination — Weeks 1 to 52","Laboratory tests — Weeks 1 to 52","electrocardiogram（ ECG ） — Weeks 1 to 52","Antibiotic antibodies (ADA) — Weeks 1 to 52","Adverse events（AE） — Weeks 1 to 52","Adverse events of particular concern (possible adverse reactions to the eye) — Weeks 1 to 52"],"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/41664","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}