{"type":"trials","record":{"id":41682,"source_id":"clinicaltrials-gov","external_id":"NCT06591598","title":"A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration","brief_summary":"Researchers are looking for a better way to treat participants who have diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. DME is a leading cause of vision loss in working age adults. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. The study treatment Aflibercept (also called BAY 86-5321) is a drug that blocks a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. The main purpose of this study is to to collect more information on the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with DME or nAMD. For this, the researchers will analyze Maximum observed concentration (Cmax): the highest amount of aflibercept in participants' blood will be measured after multiple doses of aflibercept during the study. Participants will receive 8 mg aflibercept as injections into the vitreous cavity (jelly-like substance that fills the centre of the eye) of both eyes. Participants will be divided into three groups and will receive initial and maintenance injections of 8 mg aflibercept in both eyes. Researchers will closely monitor the health of the participants during the study. During the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * examine heart health using electrocardiogram (ECG) * check vital signs such as blood pressure, heart rate, body temperature * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Bayer","enrollment":51,"countries":["Czechia","Hungary","Slovakia"],"start_date":"2024-09-02","completion_date":"2025-10-14","last_update_date":"2025-11-03","source_url":"https://clinicaltrials.gov/study/NCT06591598","editorial_summary":"A registered PHASE4 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":"DEUTERON","age_range":"18 Years","comparator":null,"organization":"Bayer","interventions":["Aflibercept (BAY86-5321, Eylea)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Maximum observed concentration (Cmax) of free aflibercept — Up to 52 weeks"],"design_description":"NON RANDOMIZED · PARALLEL · OTHER · NONE","source_has_results":false},"controlled_terms":["Diabetic Macular Edema","Neovascular Age-related Macular Degeneration","Aflibercept (BAY86-5321, Eylea)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct06591598","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-09-02 to 2025-10-14","comparator":null,"confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.853Z","intervention":["Aflibercept (BAY86-5321, Eylea)"],"participants":51,"study_design":"NON RANDOMIZED · PARALLEL · OTHER · 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":["Maximum observed concentration (Cmax) of free aflibercept — Up to 52 weeks"],"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.","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":["title","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/41682","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}