{"type":"trials","record":{"id":41728,"source_id":"clinicaltrials-gov","external_id":"NCT04423718","title":"Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye","brief_summary":"In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Bayer","enrollment":1011,"countries":["United States","Argentina","Australia","Austria","Bulgaria","Canada","China","Czechia","Estonia","France","Georgia","Hungary","Israel","Italy","Japan","Latvia","Lithuania","Portugal","Russia","Serbia","Singapore","Slovakia","South Korea","Spain","Switzerland","Taiwan","Ukraine"],"start_date":"2020-08-11","completion_date":"2024-08-07","last_update_date":"2025-08-29","source_url":"https://clinicaltrials.gov/study/NCT04423718","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":"PULSAR","age_range":"50 Years","comparator":"Aflibercept 2q8","organization":"Bayer","interventions":["Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)","Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 — At baseline and Week 48","Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 — At baseline and Week 60","Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 1…","Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48 — At baseline and Week 48","Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Wee…","Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48 — At baseline and Week 48","Change in Total Lesion Area From Baseline to Week 48 — At baseline and Week 48","Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Wee…","Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48 — At baseline and Week 48","Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48…","Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept Fro…","Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response — Up to week 96"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Neovascular Age-Related Macular Degeneration","Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)","Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct04423718","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-08-11 to 2024-08-07","comparator":"Aflibercept 2q8","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":"2026-09-25T06:20:47.861Z","intervention":["Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)","Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)"],"participants":1011,"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":["Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 — At baseline and Week 48","Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60 — At baseline and Week 60","Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 1…","Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48 — At baseline and Week 48","Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Wee…","Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48 — At baseline and Week 48","Change in Total Lesion Area From Baseline to Week 48 — At baseline and Week 48","Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Wee…","Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48 — At baseline and Week 48","Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48…","Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept Fro…","Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response — Up 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":["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":["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/41728","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}