{"type":"trials","record":{"id":41559,"source_id":"clinicaltrials-gov","external_id":"NCT05112861","title":"A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders","brief_summary":"The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.","overall_status":"Active Not Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Outlook Therapeutics, Inc.","enrollment":120,"countries":["United States"],"start_date":"2021-11-15","completion_date":"2027-12-01","last_update_date":"2026-04-22","source_url":"https://clinicaltrials.gov/study/NCT05112861","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. 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":"NORSE SEVEN","age_range":"18 Years","comparator":null,"organization":"Outlook Therapeutics, Inc.","interventions":["bevacizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","Neovascular Age-related Macular Degeneration","Wet Macular Degeneration","BRVO - Branch Retinal Vein Occlusion","Diabetic Macular Edema","bevacizumab"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct05112861","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-11-15 to 2027-12-01","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":["bevacizumab"],"participants":120,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","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":["Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or…"],"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/41559","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}