{"type":"trials","record":{"id":41511,"source_id":"clinicaltrials-gov","external_id":"NCT05989126","title":"Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)","brief_summary":"Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial. This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD). The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Regeneron Pharmaceuticals","enrollment":35,"countries":["United States"],"start_date":"2024-04-15","completion_date":"2024-05-31","last_update_date":"2026-05-28","source_url":"https://clinicaltrials.gov/study/NCT05989126","editorial_summary":"A registered PHASE3 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":null,"age_range":"18 Years","comparator":null,"organization":"Regeneron Pharmaceuticals","interventions":["aflibercept 8 mg PFS"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS — At Day 1","Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye — Through Day…","Number of Participants With at Least One Ocular Serious TEAE in the Study Eye — Through Day 29"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Diabetic Macular Edema (DME)","Neovascular Age-Related Macular Degeneration (nAMD)","aflibercept 8 mg PFS"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05989126","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-04-15 to 2024-05-31","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":"2026-09-25T06:20:47.825Z","intervention":["aflibercept 8 mg PFS"],"participants":35,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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 8 mg Aflibercept Injections Successfully Administered Utilizing the PFS — At Day 1","Number of Participants With at Least One Ocular Treatment-emergent Adverse Event (TEAE) in the Study Eye — Through Day…","Number of Participants With at Least One Ocular Serious TEAE in the Study Eye — Through Day 29"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/41511","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}