{"type":"trials","record":{"id":41645,"source_id":"clinicaltrials-gov","external_id":"NCT07275840","title":"A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD","brief_summary":"This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.","overall_status":"Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Innovent Biologics Technology Limited (Shanghai R&D Center)","enrollment":800,"countries":["China"],"start_date":"2025-12-05","completion_date":"2026-08-30","last_update_date":"2026-01-08","source_url":"https://clinicaltrials.gov/study/NCT07275840","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: 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","comparator":null,"organization":"Innovent Biologics Technology Limited (Shanghai R&D Center)","interventions":["IBI302 8mg dose"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters…","The changes in BCVA from baseline at each visit — Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52","Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 — Week52","Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 — Wee…","The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 — Week52","Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 — Week52","Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseli…","Change in CNV leakage area on FFA at week 52 compared to baseline — Week52","Proportion of participants with new-onset MA on OCT at Week 52 — Week52","Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 — Week52","Change in MA area on OCT from baseline at Week 52 — Week52","Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 — Week52","The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatm…","The production of anti-drug antibodies in the serum — Day0、Week4、Week16、Week32、Week48、Week52"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","IBI302 8mg dose"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":85,"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:nct07275840","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-12-05 to 2026-08-30","comparator":null,"confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.847Z","intervention":["IBI302 8mg dose"],"participants":800,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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":["Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters…","The changes in BCVA from baseline at each visit — Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52","Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 — Week52","Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 — Wee…","The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 — Week52","Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 — Week52","Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseli…","Change in CNV leakage area on FFA at week 52 compared to baseline — Week52","Proportion of participants with new-onset MA on OCT at Week 52 — Week52","Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 — Week52","Change in MA area on OCT from baseline at Week 52 — Week52","Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 — Week52","The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatm…","The production of anti-drug antibodies in the serum — Day0、Week4、Week16、Week32、Week48、Week52"],"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/41645","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}