{"type":"trials","record":{"id":41393,"source_id":"clinicaltrials-gov","external_id":"NCT03683251","title":"Extension Study for the Port Delivery System With Ranibizumab (Portal)","brief_summary":"This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Hoffmann-La Roche","enrollment":1000,"countries":["United States","Argentina","Australia","Austria","Belgium","Brazil","France","Germany","Israel","Italy","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom"],"start_date":"2018-09-20","completion_date":"2029-12-31","last_update_date":"2026-08-31","source_url":"https://clinicaltrials.gov/study/NCT03683251","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":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"Portal","age_range":"50 Years","comparator":null,"organization":"Hoffmann-La Roche","interventions":["PDS Implant with Ranibizumab 100 mg/mL"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) — Baseline up to Week 240","Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) — Baseline up to Week 240","Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Init…","Incidence and Severity of Adverse Device Effects — Baseline up to Week 240","Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects — Baseline up to Week 240","Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit Afte…","Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AE…","Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs — Baseline t…","Sub-study 2: Duration of AESIs — Baseline to Week 72","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period — U…","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period — > 37 d…","Sub-study 2: Duration of Ocular AESIs During the Post-operative Period — Up to Day 37 post re-implantation","Sub-study 2: Duration of Ocular AESIs During the Follow-up Period — > 37 days post re-implantation (up to approximately…","Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs — Baseline to Week 72","Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs — Baseline t…","Sub-study 2: Duration of Anticipated Serious ADEs — Baseline to Week 72","Sub-study 2: Number of Device Deficiencies — Baseline to Week 72","Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity…","Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time — Baseline up to Week…","Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time…"],"design_description":"NON RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration","PDS Implant with Ranibizumab 100 mg/mL"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct03683251","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-09-20 to 2029-12-31","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":"2026-09-25T06:20:47.804Z","intervention":["PDS Implant with Ranibizumab 100 mg/mL"],"participants":1000,"study_design":"NON 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":["Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) — Baseline up to Week 240","Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) — Baseline up to Week 240","Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Init…","Incidence and Severity of Adverse Device Effects — Baseline up to Week 240","Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects — Baseline up to Week 240","Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit Afte…","Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AE…","Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs — Baseline t…","Sub-study 2: Duration of AESIs — Baseline to Week 72","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period — U…","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period — > 37 d…","Sub-study 2: Duration of Ocular AESIs During the Post-operative Period — Up to Day 37 post re-implantation","Sub-study 2: Duration of Ocular AESIs During the Follow-up Period — > 37 days post re-implantation (up to approximately…","Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs — Baseline to Week 72","Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs — Baseline t…","Sub-study 2: Duration of Anticipated Serious ADEs — Baseline to Week 72","Sub-study 2: Number of Device Deficiencies — Baseline to Week 72","Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity…","Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time — Baseline up to Week…","Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time…"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/41393","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}