{"type":"trials","record":{"id":41383,"source_id":"clinicaltrials-gov","external_id":"NCT04853251","title":"A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)","brief_summary":"This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).","overall_status":"Recruiting","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Genentech, Inc.","enrollment":188,"countries":["United States"],"start_date":"2021-12-14","completion_date":"2027-08-31","last_update_date":"2026-09-02","source_url":"https://clinicaltrials.gov/study/NCT04853251","editorial_summary":"A registered PHASE4 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":"Belvedere","age_range":"50 Years","comparator":null,"organization":"Genentech, Inc.","interventions":["PDS Implant With Ranibizumab 100 mg/ml","LUCENTIS (Ranibizumab Injection)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the…","Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye — Baseline, Wee…","Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 i…","Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow E…","Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs — Day 1 up to approximately W…","Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs — Day 1…","Duration of Ocular AESIs — Day 1 to Week 52","Percentage of Participants With Ocular AESIs During the Postoperative Period — Baseline up to 37 days of initial implan…","Percentage of Participants With Ocular AESIs During the Intermediate Postoperative Period — 38 to 93 days after implant…","Percentage of Participants With Ocular AESIs During the Follow-up Period — Week 52","Percentage of Participants With Adverse Device Effects (ADEs) — Day 1 to Week 52","Number of Participants with Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs — Day 1 to Week…","Duration of ASADEs — Day 1 to Week 52"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","PDS Implant With Ranibizumab 100 mg/ml","LUCENTIS (Ranibizumab Injection)"],"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:nct04853251","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-12-14 to 2027-08-31","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 Implant With Ranibizumab 100 mg/ml","LUCENTIS (Ranibizumab Injection)"],"participants":188,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","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":["Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the…","Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye — Baseline, Wee…","Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 i…","Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow E…","Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs — Day 1 up to approximately W…","Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs — Day 1…","Duration of Ocular AESIs — Day 1 to Week 52","Percentage of Participants With Ocular AESIs During the Postoperative Period — Baseline up to 37 days of initial implan…","Percentage of Participants With Ocular AESIs During the Intermediate Postoperative Period — 38 to 93 days after implant…","Percentage of Participants With Ocular AESIs During the Follow-up Period — Week 52","Percentage of Participants With Adverse Device Effects (ADEs) — Day 1 to Week 52","Number of Participants with Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs — Day 1 to Week…","Duration of ASADEs — Day 1 to Week 52"],"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/41383","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}