{"type":"trials","record":{"id":41531,"source_id":"clinicaltrials-gov","external_id":"NCT06929143","title":"A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema","brief_summary":"This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision. Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which causes abnormal growth and leakage of blood vessels at the back of the eye. The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors. There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations. The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it. To learn this, the study will use 2 methods: Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg. Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg. The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2. Researchers will only look at the information from participants in Japan. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.","overall_status":"Active Not Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Bayer","enrollment":3000,"countries":["Japan"],"start_date":"2025-04-14","completion_date":"2027-07-30","last_update_date":"2026-05-12","source_url":"https://clinicaltrials.gov/study/NCT06929143","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not 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":null,"age_range":"18 Years","comparator":null,"organization":"Bayer","interventions":["Aflibercept (Eylea, BAY86-5321)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Description of baseline characteristics of patients with nAMD or DME who initiated aflibercept 8 mg under real-world co…","Description of the longitudinal patterns of treatment interval of patients with nAMD or DME who initiated aflibercept 8…","Change of treatment interval of patients with nAMD or DME who are treated with other anti-VEGF therapy. — Before and 12…","Number of injections of aflibercept 8 mg in patients with nAMD or DME. — Within 3 months, 6 months, and 12 months after…","Predicting factors of the patterns of the treatment interval of aflibercept 8 mg in patients with nAMD or DME. — Within…","Proportion of patients who continue the aflibercept 8 mg. — Within 12 months."],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Diabetic Macular Edema (DME)","Aflibercept (Eylea, BAY86-5321)"],"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:nct06929143","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-04-14 to 2027-07-30","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":"2026-09-25T06:20:47.828Z","intervention":["Aflibercept (Eylea, BAY86-5321)"],"participants":3000,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","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":["Description of baseline characteristics of patients with nAMD or DME who initiated aflibercept 8 mg under real-world co…","Description of the longitudinal patterns of treatment interval of patients with nAMD or DME who initiated aflibercept 8…","Change of treatment interval of patients with nAMD or DME who are treated with other anti-VEGF therapy. — Before and 12…","Number of injections of aflibercept 8 mg in patients with nAMD or DME. — Within 3 months, 6 months, and 12 months after…","Predicting factors of the patterns of the treatment interval of aflibercept 8 mg in patients with nAMD or DME. — Within…","Proportion of patients who continue the aflibercept 8 mg. — Within 12 months."],"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 OBSERVATIONAL."],"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/41531","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}