{"type":"trials","record":{"id":41436,"source_id":"clinicaltrials-gov","external_id":"NCT04657289","title":"A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)","brief_summary":"Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).","overall_status":"Active Not Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":451,"countries":["Argentina","Australia","Austria","Belgium","Brazil","France","Germany","Israel","Italy","Singapore","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom"],"start_date":"2021-07-14","completion_date":"2027-02-04","last_update_date":"2026-07-31","source_url":"https://clinicaltrials.gov/study/NCT04657289","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":null,"age_range":"50 Years","comparator":"Arm B [Q24W] 24-weeks between refill-exchange procedures","organization":"Hoffmann-La Roche","interventions":["Ranibizumab","Port Delivery System with Ranibizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the…","Change from baseline in BCVA score over time — Baseline up to Week 72","Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over…","Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time — B…","Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over…","Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time — B…","Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal…","Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS com…","Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire…","Percentage of participants who lose = 0 letters in BCVA score from baseline averaged over Weeks 68 and 72 — Baseline to…","Percentage of participants who lose = 0 letters in BCVA score from baseline over time — Baseline up to Week 72","Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms — Baseline up to We…","Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special int…","Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 da…","Incidence and severity of adverse device effects in the Q36W and Q24W arms — Baseline up to Week 72","Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms —…","Change from baseline in center point thickness (CPT) up to and including Week 72 — Baseline up to Week 72","Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each r…","Observed serum concentration of ranibizumab at specified timepoints — Baseline to Week 72","Incidence of treatment-emergent ADAs during the study — Baseline to Week 72"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Ranibizumab","Port Delivery System with Ranibizumab"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04657289","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-07-14 to 2027-02-04","comparator":"Arm B [Q24W] 24-weeks between refill-exchange procedures","confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.812Z","intervention":["Ranibizumab","Port Delivery System with Ranibizumab"],"participants":451,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","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":["Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the…","Change from baseline in BCVA score over time — Baseline up to Week 72","Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over…","Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time — B…","Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over…","Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time — B…","Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal…","Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS com…","Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire…","Percentage of participants who lose = 0 letters in BCVA score from baseline averaged over Weeks 68 and 72 — Baseline to…","Percentage of participants who lose = 0 letters in BCVA score from baseline over time — Baseline up to Week 72","Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms — Baseline up to We…","Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special int…","Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 da…","Incidence and severity of adverse device effects in the Q36W and Q24W arms — Baseline up to Week 72","Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms —…","Change from baseline in center point thickness (CPT) up to and including Week 72 — Baseline up to Week 72","Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each r…","Observed serum concentration of ranibizumab at specified timepoints — Baseline to Week 72","Incidence of treatment-emergent ADAs during the study — Baseline to Week 72"],"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":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title 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/41436","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}