{"type":"trials","record":{"id":41896,"source_id":"clinicaltrials-gov","external_id":"NCT06398080","title":"An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting","brief_summary":"The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration \\[AMD\\]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).","overall_status":"Withdrawn","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Regeneron Pharmaceuticals","enrollment":0,"countries":[],"start_date":"2024-12-12","completion_date":"2029-01-03","last_update_date":"2024-11-25","source_url":"https://clinicaltrials.gov/study/NCT06398080","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Withdrawn. 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":"SPECTRUM-US","age_range":"18 Years","comparator":null,"organization":"Regeneron Pharmaceuticals","interventions":["aflibercept 8 mg"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatmen…","Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters) — Baseline up to 12 Months","Change in VA (ETDRS letters) — Baseline up to 24 Months","Categorical gains of ≥5 ETDRS letters — Up to 24 Months","Categorical gains of ≥10 ETDRS letters — Up to 24 Months","Categorical gains of ≥15 ETDRS letters — Up to 24 Months","Categorical losses of ≥5 ETDRS letters — Up to 24 Months","Categorical losses of ≥10 ETDRS letters — Up to 24 Months","Categorical losses of ≥15 ETDRS letters — Up to 24 Months","Proportion of patients achieving 20/40 Snellen equivalent or better — Up to 24 Months","Change in Central subfield thickness (CST) — Baseline up to 24 Months","Description of demographics — At Baseline","Descriptions of study eye characteristics — At Baseline","Treatment interval — Up to 24 Months","Missed and unscheduled visits — Up to 24 Months","Frequency of ocular adverse events (AEs) — Up to 24 Months","Frequency of non-ocular adverse events (AEs) — Up to 24 Months"],"design_description":null,"source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Wet Age-related Macular Degeneration (AMD)","Diabetic Macular Edema (DME)","Visual Impairment","aflibercept 8 mg"],"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:nct06398080","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-12-12 to 2029-01-03","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":"2026-09-25T06:20:47.888Z","intervention":["aflibercept 8 mg"],"participants":0,"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":["Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatmen…","Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters) — Baseline up to 12 Months","Change in VA (ETDRS letters) — Baseline up to 24 Months","Categorical gains of ≥5 ETDRS letters — Up to 24 Months","Categorical gains of ≥10 ETDRS letters — Up to 24 Months","Categorical gains of ≥15 ETDRS letters — Up to 24 Months","Categorical losses of ≥5 ETDRS letters — Up to 24 Months","Categorical losses of ≥10 ETDRS letters — Up to 24 Months","Categorical losses of ≥15 ETDRS letters — Up to 24 Months","Proportion of patients achieving 20/40 Snellen equivalent or better — Up to 24 Months","Change in Central subfield thickness (CST) — Baseline up to 24 Months","Description of demographics — At Baseline","Descriptions of study eye characteristics — At Baseline","Treatment interval — Up to 24 Months","Missed and unscheduled visits — Up to 24 Months","Frequency of ocular adverse events (AEs) — Up to 24 Months","Frequency of non-ocular adverse events (AEs) — Up to 24 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/41896","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}