{"type":"trials","record":{"id":42256,"source_id":"clinicaltrials-gov","external_id":"NCT04641234","title":"A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD).","brief_summary":"In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision. The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed. The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old. All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following: * the number of aflibercept eye injections the patients received * how long the patients could wait between treatments * the change in the patients' vision * how many patients stopped treatment and why. * associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Bayer","enrollment":330,"countries":["Belgium"],"start_date":"2020-12-11","completion_date":"2021-06-09","last_update_date":"2022-06-10","source_url":"https://clinicaltrials.gov/study/NCT04641234","editorial_summary":"A registered 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":"BELUGA","age_range":"18 Years","comparator":null,"organization":"Bayer","interventions":["Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of injections in the first 24 months of treatment — Retrospective analysis in the first 24 months of treatment (…","Last injection interval in the 2nd year of treatment — Retrospective analysis in the first 24 months of treatment (1 Ja…","Number of aflibercept injections during the 1st, 3rd and 4th year of treatment — Retrospective analysis from 01-Jan-201…","Last injection interval in the 1st, 3rd and 4th year — Retrospective analysis from 01-Jan-2016 to 30-Nov-2020","Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year — Retrospective analysis from 01-Jan-2…","Number of monitoring visits during each year of the study — Retrospective analysis from 01-Jan-2016 to 30-Nov-2020","Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study — Retrospective…","Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) — Retrospective analysis from 01-Jan-2…","Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED) — Retrospective analysis from 01-Jan-2…","Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED) — Retrospective analysis from 01-Jan-20…","Reason for discontinuation of aflibercept treatment after 24 months — Retrospective analysis from 01-Jan-2016 to 30-Nov…","Number of patients discontinuing aflibercept treatment within the first 24 months — Retrospective analysis from 01-Jan-…","Reason for discontinuation of aflibercept treatment during first 24 months — Retrospective analysis from 01-Jan-2016 to…","Number of patients discontinuing aflibercept treatment after 24 months — Retrospective analysis from 01-Jan-2016 to 30-…"],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"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:nct04641234","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-11 to 2021-06-09","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":"2026-09-25T06:20:47.942Z","intervention":["Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)"],"participants":330,"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":["Number of injections in the first 24 months of treatment — Retrospective analysis in the first 24 months of treatment (…","Last injection interval in the 2nd year of treatment — Retrospective analysis in the first 24 months of treatment (1 Ja…","Number of aflibercept injections during the 1st, 3rd and 4th year of treatment — Retrospective analysis from 01-Jan-201…","Last injection interval in the 1st, 3rd and 4th year — Retrospective analysis from 01-Jan-2016 to 30-Nov-2020","Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year — Retrospective analysis from 01-Jan-2…","Number of monitoring visits during each year of the study — Retrospective analysis from 01-Jan-2016 to 30-Nov-2020","Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study — Retrospective…","Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) — Retrospective analysis from 01-Jan-2…","Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED) — Retrospective analysis from 01-Jan-2…","Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED) — Retrospective analysis from 01-Jan-20…","Reason for discontinuation of aflibercept treatment after 24 months — Retrospective analysis from 01-Jan-2016 to 30-Nov…","Number of patients discontinuing aflibercept treatment within the first 24 months — Retrospective analysis from 01-Jan-…","Reason for discontinuation of aflibercept treatment during first 24 months — Retrospective analysis from 01-Jan-2016 to…","Number of patients discontinuing aflibercept treatment after 24 months — Retrospective analysis from 01-Jan-2016 to 30-…"],"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/42256","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}