{"type":"trials","record":{"id":42004,"source_id":"clinicaltrials-gov","external_id":"NCT05141994","title":"Clinical Study on the Efficacy and Safety of BAT5906 Injection","brief_summary":"This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Bio-Thera Solutions","enrollment":48,"countries":["China"],"start_date":"2020-08-26","completion_date":"2022-09-06","last_update_date":"2024-04-16","source_url":"https://clinicaltrials.gov/study/NCT05141994","editorial_summary":"A registered PHASE2 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":null,"organization":"Bio-Thera Solutions","interventions":["2.5mg of BAT5906","4mg of BAT5906"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Dose-response relationships — week 24","BCVA — week 12 ，week 48","CRT — week 12 ，week 24，week 48","95% confidence interval — week 12 ，week 24，week 48","Average times of administration — week 24，week 48"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Wet Age-related Macular Degeneration","2.5mg of BAT5906","4mg of BAT5906"],"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:nct05141994","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-08-26 to 2022-09-06","comparator":null,"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":"2026-09-25T06:20:47.906Z","intervention":["2.5mg of BAT5906","4mg of BAT5906"],"participants":48,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"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":["Dose-response relationships — week 24","BCVA — week 12 ，week 48","CRT — week 12 ，week 24，week 48","95% confidence interval — week 12 ，week 24，week 48","Average times of administration — week 24，week 48"],"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/42004","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}