{"type":"trials","record":{"id":42103,"source_id":"clinicaltrials-gov","external_id":"NCT05727397","title":"Efficacy and Safety of RC28-E Versus Aflibercept","brief_summary":"This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.","overall_status":"Unknown","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"RemeGen Co., Ltd.","enrollment":432,"countries":["China"],"start_date":"2023-03-14","completion_date":"2025-12-29","last_update_date":"2023-08-31","source_url":"https://clinicaltrials.gov/study/NCT05727397","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Unknown. 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":null,"age_range":"50 Years","comparator":"Aflibercept","organization":"RemeGen Co., Ltd.","interventions":["RC28-E","Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean change from baseline in BCVA at week 48; — Baseline, week 48","Average change in BCVA from baseline over the period week 36 through week 48; — Baseline, weeks 36, 40, 44 and 48.","Proportion of subjects with q12w injection; — Baseline, week 48","Proportion of subjects with q12w injection at week 48 within the subjects with no q8w injection need at week 16, week 2…","Proportion of subjects with gain in BCVA of 15/10/5/0 letters or more from baseline to week 48; — Baseline, week 48","Mean change in CST from baseline to week 16, week 48; — Baseline, week 16, 48","Average change in CST from baseline over the period week 36 through week 48; — Baseline, weeks 36, 40, 44 and 48.","Proportion of subjects with presence of intraretinal fluid/subretinal fluid at week 16, week 48; — Baseline, week 16, 48","Percentage of subjects with disease activity present at week 16; — Baseline, week 16","Change in choroidal neovascularization (CNV) lesion size from baseline to week 12, week 48; — Baseline, week 12, 48","Proportion of subjects with q8w treatment need at weeks 16, 20, 28, 32, 40, 44; — Weeks 16, 20, 28, 32, 40, 44","Incidence and characteristics of ocular and systemic treatment emergent adverse events. — Baseline, week 48"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Wet Age-related Macular Degeneration","RC28-E","Aflibercept"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct05727397","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-03-14 to 2025-12-29","comparator":"Aflibercept","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":"2026-09-25T06:20:47.920Z","intervention":["RC28-E","Aflibercept"],"participants":432,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Mean change from baseline in BCVA at week 48; — Baseline, week 48","Average change in BCVA from baseline over the period week 36 through week 48; — Baseline, weeks 36, 40, 44 and 48.","Proportion of subjects with q12w injection; — Baseline, week 48","Proportion of subjects with q12w injection at week 48 within the subjects with no q8w injection need at week 16, week 2…","Proportion of subjects with gain in BCVA of 15/10/5/0 letters or more from baseline to week 48; — Baseline, week 48","Mean change in CST from baseline to week 16, week 48; — Baseline, week 16, 48","Average change in CST from baseline over the period week 36 through week 48; — Baseline, weeks 36, 40, 44 and 48.","Proportion of subjects with presence of intraretinal fluid/subretinal fluid at week 16, week 48; — Baseline, week 16, 48","Percentage of subjects with disease activity present at week 16; — Baseline, week 16","Change in choroidal neovascularization (CNV) lesion size from baseline to week 12, week 48; — Baseline, week 12, 48","Proportion of subjects with q8w treatment need at weeks 16, 20, 28, 32, 40, 44; — Weeks 16, 20, 28, 32, 40, 44","Incidence and characteristics of ocular and systemic treatment emergent adverse events. — Baseline, week 48"],"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/42103","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}