{"type":"trials","record":{"id":41880,"source_id":"clinicaltrials-gov","external_id":"NCT06176963","title":"A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO","brief_summary":"This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Samsung Bioepis Co., Ltd.","enrollment":34,"countries":["Poland"],"start_date":"2023-11-21","completion_date":"2023-12-12","last_update_date":"2024-12-30","source_url":"https://clinicaltrials.gov/study/NCT06176963","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":"18 Years","comparator":null,"organization":"Samsung Bioepis Co., Ltd.","interventions":["SB11 PFS"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of Successful Task Completions — Day 1","Percentage of Successful Completion on Critical Tasks — Day 1","Percentage of Successful Completion on Essential Tasks — Day 1"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","Macular Edema","Retinal Vein Occlusion","SB11 PFS"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06176963","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-11-21 to 2023-12-12","comparator":null,"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":"2026-09-25T06:20:47.885Z","intervention":["SB11 PFS"],"participants":34,"study_design":"NA · SINGLE GROUP · 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":["Percentage of Successful Task Completions — Day 1","Percentage of Successful Completion on Critical Tasks — Day 1","Percentage of Successful Completion on Essential Tasks — Day 1"],"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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/41880","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}