{"type":"trials","record":{"id":41558,"source_id":"clinicaltrials-gov","external_id":"NCT07550504","title":"A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV","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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Samsung Bioepis Co., Ltd.","enrollment":30,"countries":["Poland"],"start_date":"2026-03-30","completion_date":"2026-04-09","last_update_date":"2026-04-24","source_url":"https://clinicaltrials.gov/study/NCT07550504","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 on All of the 12 tasks — Day 1","Percentage of Successful Completion on Each of 12 tasks — Day 1","Incidence of AEs and serious adverse events (SAEs) — From Day 1 to Day 7","Change from baseline in Best Corrected Visual Acuity (BCVA) — From Day 1 to Day 7"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Branch Retinal Vein Occlusion With Macular Edema","Central Retinal Vein Occlusion With Macular Edema","Myopic Choroidal Neovascularization","SB11 PFS"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"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:nct07550504","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-03-30 to 2026-04-09","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":"2026-09-25T06:20:47.833Z","intervention":["SB11 PFS"],"participants":30,"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 on All of the 12 tasks — Day 1","Percentage of Successful Completion on Each of 12 tasks — Day 1","Incidence of AEs and serious adverse events (SAEs) — From Day 1 to Day 7","Change from baseline in Best Corrected Visual Acuity (BCVA) — From Day 1 to Day 7"],"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/41558","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}