{"type":"trials","record":{"id":28308,"source_id":"clinicaltrials-gov","external_id":"NCT06847542","title":"A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD","brief_summary":"The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":250,"countries":["Austria","Czechia","Denmark","France","Germany","Greece","Italy","Poland","South Korea","Spain","Switzerland","Thailand","United Kingdom"],"start_date":"2025-11-27","completion_date":"2028-11-15","last_update_date":"2026-09-21","source_url":"https://clinicaltrials.gov/study/NCT06847542","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"Sightspire","age_range":"50 Years","comparator":null,"organization":"Hoffmann-La Roche","interventions":["Susvimo PDS Implant","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 — From baseline up to Week 72","Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time — From b…","Change From Baseline in Center Point Thickness (CPT) — From baseline up to Week 72","Change From Baseline in Central Subfield Thickness (CST) — From baseline up to Week 72","Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange P…","Number of Supplemental Treatments Participants Received in Each Refill Cycle — Up to Week 72","Frequency of Study Visits in Each Refill Cycle — Up to Week 72","Proportion of Participants Who Report Preferring PDS Compared With IVT Ranibizumab Treatment as Measured by the PDS Pat…","Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Mea…","Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) — Up to approximately 19 months","Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs — Up…","Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period —…","Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs With PDS — Up to approximately 19 months","Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS — Up to…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Susvimo PDS Implant","Ranibizumab"],"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:nct06847542","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-11-27 to 2028-11-15","comparator":null,"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":"2026-09-25T06:20:47.793Z","intervention":["Susvimo PDS Implant","Ranibizumab"],"participants":250,"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":["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 — From baseline up to Week 72","Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time — From b…","Change From Baseline in Center Point Thickness (CPT) — From baseline up to Week 72","Change From Baseline in Central Subfield Thickness (CST) — From baseline up to Week 72","Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange P…","Number of Supplemental Treatments Participants Received in Each Refill Cycle — Up to Week 72","Frequency of Study Visits in Each Refill Cycle — Up to Week 72","Proportion of Participants Who Report Preferring PDS Compared With IVT Ranibizumab Treatment as Measured by the PDS Pat…","Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Mea…","Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) — Up to approximately 19 months","Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs — Up…","Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period —…","Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs With PDS — Up to approximately 19 months","Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS — Up to…"],"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/28308","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}