{"type":"trials","record":{"id":42015,"source_id":"clinicaltrials-gov","external_id":"NCT04864834","title":"Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration","brief_summary":"Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Sandoz","enrollment":485,"countries":["United States","Australia","Austria","Bulgaria","Czechia","France","Germany","Hungary","Israel","Japan","Latvia","Lithuania","Poland","Portugal","Slovakia","Spain"],"start_date":"2021-05-12","completion_date":"2023-05-10","last_update_date":"2024-03-26","source_url":"https://clinicaltrials.gov/study/NCT04864834","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":"Mylight","age_range":"50 Years","comparator":"Eylea EU (40 mg/mL)","organization":"Sandoz","interventions":["SOK583A1 (40 mg/mL)","Eylea EU (40 mg/mL)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters.…","Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU — Week 1, 4, 8, 24 and 52","Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU — Week 8 and 52","Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA — Week 24 and 52","Similarity Between SOK583A1 and Eylea EU in Terms of Safety — 52 weeks","Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity — Week 52","Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment — Baseline (pre-dose)…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","SOK583A1 (40 mg/mL)","Eylea EU (40 mg/mL)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct04864834","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-05-12 to 2023-05-10","comparator":"Eylea EU (40 mg/mL)","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":"2026-09-25T06:20:47.908Z","intervention":["SOK583A1 (40 mg/mL)","Eylea EU (40 mg/mL)"],"participants":485,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters.…","Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU — Week 1, 4, 8, 24 and 52","Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU — Week 8 and 52","Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA — Week 24 and 52","Similarity Between SOK583A1 and Eylea EU in Terms of Safety — 52 weeks","Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity — Week 52","Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment — Baseline (pre-dose)…"],"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/42015","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}