{"type":"trials","record":{"id":28316,"source_id":"clinicaltrials-gov","external_id":"NCT06541704","title":"A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","brief_summary":"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Regeneron Pharmaceuticals","enrollment":975,"countries":["United States","Australia","Austria","Canada","France","Germany","Hungary","Italy","Poland","Spain","United Kingdom"],"start_date":"2024-10-30","completion_date":"2033-04-09","last_update_date":"2026-09-18","source_url":"https://clinicaltrials.gov/study/NCT06541704","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: 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":"SIENNA","age_range":"50 Years to 85 Years","comparator":"Placebo treatment group","organization":"Regeneron Pharmaceuticals","interventions":["Pozelimab","Cemdisiran","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) — To…","Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from basel…","Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA) — At week 52 and week 104","Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA) — At week 52 and week 104","Change from baseline in quantitative Contrast Sensitivity Function (qCSF) — At week 52 and week 104","Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF — To week 104","Concentrations of total pozelimab in serum — Through week 52 and through week 104","Concentrations of total cemdisiran in plasma — Through week 52 and through week 104","Change from baseline in concentration of total Complement component 5 (C5) — Through week 52 and through week 104","Incidence of Antidrug antibody (ADA) to pozelimab — Through week 52 and through week 104","Magnitude of ADA to pozelimab — Through week 52 and through week 104","Incidence of ADA to cemdisiran — Through week 52 and through week 104","Magnitude of ADA to cemdisiran — Through week 52 and through week 104","Incidence of Neutralizing Antibody (NAb) to pozelimab — Through week 52 and through week 104","Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Through week 52, 104, 140 and week 296","Severity of TEAEs — Through week 52, 104, 140 and week 296"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)","Pozelimab","Cemdisiran","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06541704","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-10-30 to 2033-04-09","comparator":"Placebo treatment group","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":"2026-09-25T06:20:47.795Z","intervention":["Pozelimab","Cemdisiran","Placebo"],"participants":975,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) — To…","Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from basel…","Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA) — At week 52 and week 104","Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA) — At week 52 and week 104","Change from baseline in quantitative Contrast Sensitivity Function (qCSF) — At week 52 and week 104","Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF — To week 104","Concentrations of total pozelimab in serum — Through week 52 and through week 104","Concentrations of total cemdisiran in plasma — Through week 52 and through week 104","Change from baseline in concentration of total Complement component 5 (C5) — Through week 52 and through week 104","Incidence of Antidrug antibody (ADA) to pozelimab — Through week 52 and through week 104","Magnitude of ADA to pozelimab — Through week 52 and through week 104","Incidence of ADA to cemdisiran — Through week 52 and through week 104","Magnitude of ADA to cemdisiran — Through week 52 and through week 104","Incidence of Neutralizing Antibody (NAb) to pozelimab — Through week 52 and through week 104","Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Through week 52, 104, 140 and week 296","Severity of TEAEs — Through week 52, 104, 140 and week 296"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/28316","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}