{"type":"trials","record":{"id":41388,"source_id":"clinicaltrials-gov","external_id":"NCT05562947","title":"A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)","brief_summary":"This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.","overall_status":"Active Not Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":68,"countries":["China"],"start_date":"2024-06-17","completion_date":"2029-07-31","last_update_date":"2026-09-01","source_url":"https://clinicaltrials.gov/study/NCT05562947","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":"HUTONG","age_range":"50 Years","comparator":null,"organization":"Hoffmann-La Roche","interventions":["PDS With Ranibizumab (100 mg/mL)","Ranibizumab (10 mg/mL)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Averaged Over Weeks 36 and 40, as Assessed Using the…","Change From Baseline in BCVA Score Over Time — Baseline up to Week 144","Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over…","Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged over…","Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged Over…","Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40 — Baseline up…","Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48 — Baseline up…","Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40 — Bas…","Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48 — Bas…","Change From Baseline in Center Point Thickness (CPT) at Week 36 — Baseline and Week 36","Change From Baseline in Central Subfield Thickness (CST) at Week 36 — Baseline and Week 36","Change From Baseline in CPT at Week 44 — Baseline and Week 44","Change From Baseline in CST at Week 44 — Baseline and Week 44","Proportion of Participants in the Implant Arm Who do not Undergo Supplemental Treatment With IVT Ranibizumab 0.5 mg Bef…","Proportion of Participants in the Implant Arm Who do not Undergo a Supplemental Treatment that Requires Subsequent Addi…","Percentage of Participants With Adverse Events (AEs) — Baseline up to 144 weeks","Percentage of Participants With Adverse Events of Special Interest (AESIs) — Baseline up to 144 weeks","Duration of AESIs — Baseline up to 144 weeks","Percentage of Participants With Ocular AESIs During the Post-operative Period and Follow-up Period — Post-operative per…","Percentage of Participants Who Received PDS Affected With Adverse Device Effects (ADEs) — Baseline up to 144 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","nAMD","PDS With Ranibizumab (100 mg/mL)","Ranibizumab (10 mg/mL)"],"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:nct05562947","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-06-17 to 2029-07-31","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":"2026-09-25T06:20:47.803Z","intervention":["PDS With Ranibizumab (100 mg/mL)","Ranibizumab (10 mg/mL)"],"participants":68,"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 36 and 40, as Assessed Using the…","Change From Baseline in BCVA Score Over Time — Baseline up to Week 144","Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over…","Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged over…","Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged Over…","Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40 — Baseline up…","Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48 — Baseline up…","Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40 — Bas…","Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48 — Bas…","Change From Baseline in Center Point Thickness (CPT) at Week 36 — Baseline and Week 36","Change From Baseline in Central Subfield Thickness (CST) at Week 36 — Baseline and Week 36","Change From Baseline in CPT at Week 44 — Baseline and Week 44","Change From Baseline in CST at Week 44 — Baseline and Week 44","Proportion of Participants in the Implant Arm Who do not Undergo Supplemental Treatment With IVT Ranibizumab 0.5 mg Bef…","Proportion of Participants in the Implant Arm Who do not Undergo a Supplemental Treatment that Requires Subsequent Addi…","Percentage of Participants With Adverse Events (AEs) — Baseline up to 144 weeks","Percentage of Participants With Adverse Events of Special Interest (AESIs) — Baseline up to 144 weeks","Duration of AESIs — Baseline up to 144 weeks","Percentage of Participants With Ocular AESIs During the Post-operative Period and Follow-up Period — Post-operative per…","Percentage of Participants Who Received PDS Affected With Adverse Device Effects (ADEs) — Baseline up to 144 weeks"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","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/41388","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}