{"type":"trials","record":{"id":41541,"source_id":"clinicaltrials-gov","external_id":"NCT07340372","title":"Home Monitoring in eAMD Treatment","brief_summary":"The goal of this observational clinical study is to collect more information about the efficacy of Aflibercept 8 mg injections in people with eAMD. The main questions it aims to answer are: * To reassure patients and doctors with longer intervals using home monitoring app; * To assess patient reported outcomes (PROMs) and Value-based Healthcare. Participants already taking Aflibercept 8 mg as part of their regular medical care for eAMD will undergo regular ophthalmological examination and use a home monitoring app, in a one year and a two-year treatment period.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Association for Innovation and Biomedical Research on Light and Image","enrollment":80,"countries":["Portugal"],"start_date":"2026-05-01","completion_date":"2027-12-01","last_update_date":"2026-05-06","source_url":"https://clinicaltrials.gov/study/NCT07340372","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet 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":"HOME","age_range":"55 Years","comparator":null,"organization":"Association for Innovation and Biomedical Research on Light and Image","interventions":["Aflibercept 8mg"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Average change in best corrected visual acuity (BCVA) from baseline to month 12. — From baseline and then at each of th…","Average change in BCVA from baseline to month 24. — From baseline and then at each of the subsequent visits until month…","Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12. — From baseline through month 12.","Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24. — From baseline through month 24.","Proportion of patients with BCVA ≥69 letters at month 12. — From baseline through month 12.","Proportion of patients with BCVA ≥69 letters at month 24. — From baseline through month 24.","Average change in central retinal thickness (CRT) from baseline to month 12. — From baseline to month 12.","Average change in CRT from baseline to month 24. — From baseline to month 24.","Proportion of patients without fluid at foveal centre at month 12. — Month 12.","Proportion of patients without fluid at foveal centre at month 24. — Month 24.","Total number of visits during the two-year treatment period. — From baseline through end of study (24 months).","Total number of intravitreal injections during the two-year treatment period. — From baseline through end of study (24…","Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12. — Month 12.","Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24. — Month 24.","Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts. — From…","Proportion of inaccurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts. — Fr…","Adherence to the home monitoring. — From baseline to the end of the study.","Costs assigned to National Health System at month 12. — Month 12.","Costs assigned to National Health System at month 24. — Month 24.","Societal costs at month 12. — Month 12."],"design_description":null,"source_has_results":false},"controlled_terms":["Exudative Age-Related Macular Degeneration","Aflibercept 8mg"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct07340372","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-05-01 to 2027-12-01","comparator":null,"confidence":"structured-source","population":"ALL · 55 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":"2026-09-25T06:20:47.830Z","intervention":["Aflibercept 8mg"],"participants":80,"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":["Average change in best corrected visual acuity (BCVA) from baseline to month 12. — From baseline and then at each of th…","Average change in BCVA from baseline to month 24. — From baseline and then at each of the subsequent visits until month…","Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12. — From baseline through month 12.","Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24. — From baseline through month 24.","Proportion of patients with BCVA ≥69 letters at month 12. — From baseline through month 12.","Proportion of patients with BCVA ≥69 letters at month 24. — From baseline through month 24.","Average change in central retinal thickness (CRT) from baseline to month 12. — From baseline to month 12.","Average change in CRT from baseline to month 24. — From baseline to month 24.","Proportion of patients without fluid at foveal centre at month 12. — Month 12.","Proportion of patients without fluid at foveal centre at month 24. — Month 24.","Total number of visits during the two-year treatment period. — From baseline through end of study (24 months).","Total number of intravitreal injections during the two-year treatment period. — From baseline through end of study (24…","Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12. — Month 12.","Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24. — Month 24.","Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts. — From…","Proportion of inaccurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts. — Fr…","Adherence to the home monitoring. — From baseline to the end of the study.","Costs assigned to National Health System at month 12. — Month 12.","Costs assigned to National Health System at month 24. — Month 24.","Societal costs at month 12. — Month 12."],"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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/41541","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}