{"type":"trials","record":{"id":41475,"source_id":"clinicaltrials-gov","external_id":"NCT06075147","title":"The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema","brief_summary":"This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is 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. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.","overall_status":"Active Not Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Bayer","enrollment":2500,"countries":["Australia","Canada","Denmark","Finland","France","Germany","Italy","Japan","Netherlands","Norway","Portugal","Saudi Arabia","South Korea","Spain","Sweden","Switzerland","United Arab Emirates","United Kingdom"],"start_date":"2024-02-15","completion_date":"2028-01-31","last_update_date":"2026-06-30","source_url":"https://clinicaltrials.gov/study/NCT06075147","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 8 mg (VEGF Trap-Eye, BAY86-5321)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice…","The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluat…","Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the secon…","Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 mo…","Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 week…","Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks…","Number of participants with (serious) adverse events and (serious) drug-related adverse events — From the first applica…"],"design_description":null,"source_has_results":false},"controlled_terms":["Visual Impairment","Neovascular Age-related Macular Degeneration (nAMD)","Diabetic Macula Edema (DME)","Aflibercept 8 mg (VEGF Trap-Eye, 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:nct06075147","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-02-15 to 2028-01-31","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":"2026-09-25T06:20:47.819Z","intervention":["Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)"],"participants":2500,"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":["The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice…","The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluat…","Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the secon…","Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 mo…","Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 week…","Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks…","Number of participants with (serious) adverse events and (serious) drug-related adverse events — From the first applica…"],"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/41475","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}