{"type":"trials","record":{"id":42050,"source_id":"clinicaltrials-gov","external_id":"NCT05126966","title":"A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration","brief_summary":"This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).","overall_status":"Withdrawn","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":0,"countries":["Argentina","Denmark","Greece","Hong Kong","Portugal","Spain","Thailand"],"start_date":"2023-12-29","completion_date":"2026-01-30","last_update_date":"2024-01-18","source_url":"https://clinicaltrials.gov/study/NCT05126966","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Withdrawn. 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":"Diagrid","age_range":"50 Years","comparator":"Aflibercept","organization":"Hoffmann-La Roche","interventions":["Ranibizumab","Aflibercept","Port Delivery System with ranibizumab (PDS)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline in BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of…","Treatment burden as assessed by the treatment frequency up to Week 80 — From baseline up to 80 weeks","Proportion of subjects with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Wee…","Proportion of subjects with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Wee…","Proportion of subjects who lose < 15, < 10, or < 5 letters in BCVA score from baseline averaged over Weeks 76 (or 78*)…","Change from baseline in center point thickness (CPT) at Week 80 — Baseline, Week 80","Change from baseline in center subfield thickness (CST), defined as the average thickness of the central 1 mm circle of…","Proportion of subjects randomized to PDS Q36W who do not undergo supplemental treatment with intravitreal ranibizumab 0…","Incidence and severity of ocular and systemic (non-ocular) adverse events — Baseline, Week 80","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 with PDS Q36W — Baseline, Week 80","Incidence, causality, severity, and duration of anticipated serious adverse device effects with PDS Q36W — Baseline, We…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration","Ranibizumab","Aflibercept","Port Delivery System with ranibizumab (PDS)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct05126966","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-12-29 to 2026-01-30","comparator":"Aflibercept","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":"2026-09-25T06:20:47.912Z","intervention":["Ranibizumab","Aflibercept","Port Delivery System with ranibizumab (PDS)"],"participants":0,"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 BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of…","Treatment burden as assessed by the treatment frequency up to Week 80 — From baseline up to 80 weeks","Proportion of subjects with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Wee…","Proportion of subjects with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Wee…","Proportion of subjects who lose < 15, < 10, or < 5 letters in BCVA score from baseline averaged over Weeks 76 (or 78*)…","Change from baseline in center point thickness (CPT) at Week 80 — Baseline, Week 80","Change from baseline in center subfield thickness (CST), defined as the average thickness of the central 1 mm circle of…","Proportion of subjects randomized to PDS Q36W who do not undergo supplemental treatment with intravitreal ranibizumab 0…","Incidence and severity of ocular and systemic (non-ocular) adverse events — Baseline, Week 80","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 with PDS Q36W — Baseline, Week 80","Incidence, causality, severity, and duration of anticipated serious adverse device effects with PDS Q36W — Baseline, We…"],"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/42050","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}