{"type":"trials","record":{"id":41927,"source_id":"clinicaltrials-gov","external_id":"NCT05473715","title":"A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment","brief_summary":"Researchers are looking for a better way to treat people who have neovascular (wet) age-related macular degeneration (nAMD or wet AMD). In people with wet AMD, the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in the area of sharpest vision in the eye, called macula. Fluid buildup due to leakage from these vessels can damage the macula, leading to vision problems such as blurring or a blind spot in the central (straight ahead) vision needed for reading or face recognition or car driving. Wet AMD is common in people aged 50 and older. The study treatment intravitreal aflibercept (also called BAY865321) is injected into the eye. It works by blocking the VEGF protein and thus reduces blood vessel growth. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start and then every 8 weeks or longer. Repeated injections of aflibercept prevent worsening of vision but place a burden on the patient. Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T\\&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye. The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster (timepoint of extension is the same for both treatments arms), compared to standard T\\&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation. To answer this, researchers will assess changes in vision called best corrected visual acuity (BCVA) between study start and after 36 weeks. Changes will then be compared between participants whose treatment intervals were extended early and those on standard T\\&E regimen. All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks. Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually. A final phone call is planned 3 days after treatment at the end of study. During the study, the doctors and their study team will: * check patients' eye health using various eye examination techniques (slit lamp microscopy, OCT, and ophthalmoscopy) that may necessitate eye drops to widen the pupil) * measure patients' eye vision (BCVA) * do physical examinations * check vital signs * 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 that happen in studies, even if they do not think the adverse events might be rela…","overall_status":"Terminated","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Bayer","enrollment":3,"countries":["Canada","United Kingdom"],"start_date":"2023-04-25","completion_date":"2023-07-11","last_update_date":"2024-10-16","source_url":"https://clinicaltrials.gov/study/NCT05473715","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Terminated. 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":"XPAND","age_range":"50 Years","comparator":"Treat and extend (T&E) 2 week adjustment","organization":"Bayer","interventions":["Aflibercept(BAY86-5321, Eylea)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Best-corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters) — Approximat…","Number of Intravitreal (IVT) Aflibercept Injections — Approximately 11 weeks","Number of Patients Achieving Pre-defined Treatment Intervals — Approximately 11 weeks","Change in BCVA (ETDRS Letters) — Approximately 11 weeks","Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TE…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Neovascular (Wet) Age-related Macular Degeneration","Aflibercept(BAY86-5321, Eylea)"],"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:nct05473715","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-04-25 to 2023-07-11","comparator":"Treat and extend (T&E) 2 week adjustment","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":"2026-09-25T06:20:47.893Z","intervention":["Aflibercept(BAY86-5321, Eylea)"],"participants":3,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["Change in Best-corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters) — Approximat…","Number of Intravitreal (IVT) Aflibercept Injections — Approximately 11 weeks","Number of Patients Achieving Pre-defined Treatment Intervals — Approximately 11 weeks","Change in BCVA (ETDRS Letters) — Approximately 11 weeks","Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TE…"],"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/41927","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}