{"type":"trials","record":{"id":28331,"source_id":"clinicaltrials-gov","external_id":"NCT07817615","title":"A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion","brief_summary":"This is a Phase I, multicenter, open-label, dose-escalation study conducted in two parts to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GenSci148 administered via intravitreal (IVT) injection in participants with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Part 1 evaluates single ascending doses in nAMD participants. Part 2 evaluates multiple doses in nAMD, DME, and RVO participants. The study also assesses immunogenicity and explores preliminary efficacy.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","enrollment":60,"countries":["China"],"start_date":"2026-09-01","completion_date":"2028-10-01","last_update_date":"2026-09-14","source_url":"https://clinicaltrials.gov/study/NCT07817615","editorial_summary":"A registered 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":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"GenSci148-101","age_range":"18 Years to 85 Years","comparator":null,"organization":"Changchun GeneScience Pharmaceutical Co., Ltd.","interventions":["GenSci148 Injection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence and severity of treatment-emergent adverse events (TEAEs) — 43 days(Part 1) and 40 weeks (Part 2)"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration (nAMD)","Diabetic Macular Edema (DME)","Retinal Vein Occlusion (RVO)","GenSci148 Injection"],"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:nct07817615","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-01 to 2028-10-01","comparator":null,"confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.797Z","intervention":["GenSci148 Injection"],"participants":60,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"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":["Incidence and severity of treatment-emergent adverse events (TEAEs) — 43 days(Part 1) and 40 weeks (Part 2)"],"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 INTERVENTIONAL."],"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/28331","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}