{"type":"trials","record":{"id":41447,"source_id":"clinicaltrials-gov","external_id":"NCT07728981","title":"Biomarkers, Effectiveness, and Safety of Aflibercept 8mg Modified Fixed Dose Regimen in Treatment-Naïve nAMD Patients","brief_summary":"Primary objective: • To evaluate the change in aqueous humor vascular endothelial growth factor A (VEGF-A) levels after 2 months of initial treatment with 8 mg Aflibercept in treatment-naïve nAMD patients. Secondary objectives: • To assess the efficacy, safety, and biomarker changes of 8 mg Aflibercept using a modified fixed-interval dosing regimen over 12 months in treatment-naïve nAMD patients.","overall_status":"Not Yet Recruiting","phases":["EARLY_PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Tianjin Medical University Eye Hospital","enrollment":49,"countries":[],"start_date":"2026-07-25","completion_date":"2027-12-31","last_update_date":"2026-07-27","source_url":"https://clinicaltrials.gov/study/NCT07728981","editorial_summary":"A registered EARLY_PHASE1 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":null,"age_range":"50 Years to 85 Years","comparator":null,"organization":"Tianjin Medical University Eye Hospital","interventions":["Aflibercept 8mg"],"registry_source":"ClinicalTrials.gov","outcome_measures":["VEGF-A levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mon…","Proportion of patients who did not receive remedial treatment — From enrollment to the end of treatment at 12 months","best corrected visual acuity (BCVA) — From enrollment to the end of treatment at 12 months","central retinal thickness (CMT) — From enrollment to the end of treatment at 12 months","VEGF-B levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mon…","placental growth factor (PIGF) levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 mon…","Ang-2 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mont…","IL-6 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8month…","IL-8 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8month…","Average number of doses in the 12th month — \"From enrollment to the end of treatment at 12 months","the average area/volume of macular neovascularization (MNV) — From enrollment to the end of treatment at 0 month、2month…","intraretinal fluid (IRF) or subretinal fluid (SRF) in the foveal area — From enrollment to the end of treatment at 2mon…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD","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:nct07728981","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-07-25 to 2027-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years to 85 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":"2026-09-25T06:20:47.814Z","intervention":["Aflibercept 8mg"],"participants":49,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"EARLY_PHASE1","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":["VEGF-A levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mon…","Proportion of patients who did not receive remedial treatment — From enrollment to the end of treatment at 12 months","best corrected visual acuity (BCVA) — From enrollment to the end of treatment at 12 months","central retinal thickness (CMT) — From enrollment to the end of treatment at 12 months","VEGF-B levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mon…","placental growth factor (PIGF) levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 mon…","Ang-2 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8mont…","IL-6 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8month…","IL-8 levels in the patient's aqueous humor — From enrollment to the end of treatment at 0 months、2months、5months、8month…","Average number of doses in the 12th month — \"From enrollment to the end of treatment at 12 months","the average area/volume of macular neovascularization (MNV) — From enrollment to the end of treatment at 0 month、2month…","intraretinal fluid (IRF) or subretinal fluid (SRF) in the foveal area — From enrollment to the end of treatment at 2mon…"],"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 INTERVENTIONAL."],"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/41447","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}