{"type":"trials","record":{"id":42223,"source_id":"clinicaltrials-gov","external_id":"NCT03677934","title":"A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration","brief_summary":"Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \\[VA\\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":415,"countries":["United States"],"start_date":"2018-09-12","completion_date":"2021-06-09","last_update_date":"2022-10-04","source_url":"https://clinicaltrials.gov/study/NCT03677934","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":"Archway","age_range":"50 Years","comparator":"Intravitreal Arm","organization":"Hoffmann-La Roche","interventions":["PDS Implant filled with 100 mg/mL Ranibizumab","Intravitreal Injections of 10 mg/mL Ranibizumab"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Us…","Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64 — Baseline, Week60, Week 64","Change From Baseline in BCVA Score Over Time — Baseline up to Week 96","Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Averag…","Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time — B…","Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Averag…","Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time — B…","Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week…","Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time — Baseline up to Week 96","Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 — Ba…","Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time — Baseline up to Week 96","Change From Baseline in Center Point Thickness (CPT) at Week 36 — Baseline to Week 36","Change From Baseline in CPT Over Time — Baseline up to Week 96","Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5…","Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additio…","Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs — Randomization to Week 96","Percentage of Participants With Adverse Events of Special Interest — Randomization to Week 96","Observed Serum Ranibizumab Concentrations at Specified Timepoints — Randomization to Week 96","Estimated PK Parameter Values AUC0-6M — Randomization to Week 96","Estimated PK Parameter Value t1/2 After PDS Implant Insertion — Randomization to Week 96"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":true},"controlled_terms":["Neovascular Age-Related Macular Degeneration","PDS Implant filled with 100 mg/mL Ranibizumab","Intravitreal Injections of 10 mg/mL Ranibizumab"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct03677934","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-09-12 to 2021-06-09","comparator":"Intravitreal Arm","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":"2026-09-25T06:20:47.937Z","intervention":["PDS Implant filled with 100 mg/mL Ranibizumab","Intravitreal Injections of 10 mg/mL Ranibizumab"],"participants":415,"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 at the Average of Week 36 and Week 40, as Assessed Us…","Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64 — Baseline, Week60, Week 64","Change From Baseline in BCVA Score Over Time — Baseline up to Week 96","Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Averag…","Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time — B…","Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Averag…","Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time — B…","Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week…","Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time — Baseline up to Week 96","Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 — Ba…","Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time — Baseline up to Week 96","Change From Baseline in Center Point Thickness (CPT) at Week 36 — Baseline to Week 36","Change From Baseline in CPT Over Time — Baseline up to Week 96","Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5…","Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additio…","Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs — Randomization to Week 96","Percentage of Participants With Adverse Events of Special Interest — Randomization to Week 96","Observed Serum Ranibizumab Concentrations at Specified Timepoints — Randomization to Week 96","Estimated PK Parameter Values AUC0-6M — Randomization to Week 96","Estimated PK Parameter Value t1/2 After PDS Implant Insertion — Randomization to Week 96"],"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/42223","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}