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A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy

Study acronym: SIENNA
StatusRecruiting
PhasePhase 3
Started2024-10-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Nov 29, 2027 → Jul 31, 2028
See other at-risk trials from Regeneron

Amendment history

2026-08-24
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 224 sites
2026-08-13
Study Status, References v38
2026-08-10
Study Status, Contacts/Locations v37
Study sites223→224
2026-07-28
Study Status, Contacts/Locations v36
Trial sites expanded: 218 → 223 locations
Primary completion pushed: 2027-11-29 → 2028-07-31
Completion pushed: 2032-05-21 → 2033-04-09
2026-07-08
Study Status, Contacts/Locations v35
Study sites217→218
Show 3 earlier versions
2026-06-16
Study Status, Contacts/Locations v34
Study sites216→217
2026-05-25
Study Status, Contacts/Locations v33
Study sitesdetails revised at 2 of 216 sites
2026-05-06
Study Status, Contacts/Locations v32
Study sitesdetails revised at 3 of 216 sites
2026-04-07
Study Status, Contacts/Locations v31
Trial sites expanded: 210 → 216 locations
2026-03-20
Study Status, Contacts/Locations v30
Study sites208→210
2026-03-03
Study Status, Contacts/Locations v29
Study sites203→208
2026-02-25
Study Status, Contacts/Locations v28
Study sites198→203
2026-02-03
Study Status, Contacts/Locations v27
Study sites151→198
2026-01-20
Study Status, Contacts/Locations v26
Study sites139→151
2026-01-08
Study Status, Contacts/Locations v25
Study sites139 entries, revised
Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta
2025-12-16
Study Status, Contacts/Locations v24
Study sites136→139
2025-12-01
Study Status, Contacts/Locations v23
Study sites123→136
2025-11-19
Study Status, Contacts/Locations v22
Study sites123 entries, revised
Mid Atlantic Retina - Cherry Hill
2025-11-04
Study Status, Contacts/Locations v21
Study sites110→123
2025-10-06
Study Status, Contacts/Locations v20
Study sites107→110
2025-09-16
Study Status, Contacts/Locations v19
Study sites100→107
2025-09-02
Study Status, Contacts/Locations v18
Study sites97→100
2025-08-26
Study Status, Contacts/Locations v17
Study sites92→97
2025-08-07
Study Status, Contacts/Locations v16
Study sites89→92
2025-07-25
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v15
Enrollment target750→975
Study sites83→89
Eligibility criteria+115 characters
Key Inclusion Criteria: Study eye with diagnosis of GA of the macula secondary to AMD not involving the foveal center point as described in the protocol Total GA area in the study eye measuring between ≥2.5 mm2mm^2 and ≤17.5 mm2mm^2 as described in the protocol BCVA of 3555 letters or better using ETDRS charts (20/20080 Snellen equivalent) in the study eye as described in the pr [...] sion Criteria: GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic macu [...] droxychloroquine maculopathy History or current evidence of macularMacular neovascularizationNeova [...] [...]
Secondary endpoints15 entries, revised
Loss of Best correctedCorrected visualVisual acuityAcuity (BCVA) ≥15 letters [Early treatmentTreatment diabeticDiabetic retinopathyRetinopathy studyStudy (ETDRS)] lettersfrom at any 2 consecutive study visitsbaseline Change from baseline in Low-contrastContrast quantitative visualVisual acuityAcuity (LC-qVA) Change from baseline in Low-luminanceLuminance lowLow-contrastContrast quantitative visualVisual acuityAcuity (LL-LC-qVA) Change from baseline in Quantitativequantitative contrastContrast sensitivitySensitivity functionFunction (qCSF) Growth rate (slope) of total GA lesion area (mm2mm^2 /y [...] [...]
Primary endpoints1 entry, revised
Growth rate (slope) of total GA lesion area (mm2mm^2 /year) from baseline, measured by Fundus autofluorescenceAutofluorescence (FAF)
2025-07-11
Study Status, Contacts/Locations v14
Study sites78→83
2025-06-06
Study Status, Contacts/Locations v13
Study sites71→78
2025-05-21
Study Status, Contacts/Locations v12
Study sites68→71
2025-05-06
Study Status, Contacts/Locations v11
Study sites66→68
2025-04-21
Study Status, Contacts/Locations v10
Study sites46→66
2025-04-16
Study Status, Contacts/Locations v9
Study sites45→46
2025-03-07
Study Status, Contacts/Locations v8
Study sites44→45
2025-02-20
Study Status, Contacts/Locations v7
Study sites41→44
2025-02-11
Study Status, Contacts/Locations v6
Study sites30→41
2025-01-23
Study Status, Contacts/Locations v5
Study sites27→30
2025-01-10
Study Status, Contacts/Locations v4
Study sites19→27
2024-12-17
Study Status, Contacts/Locations v3
Study sites13→19
2024-12-05
Study Status, Contacts/Locations v2
Study sites8→13
2024-11-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-07-10→2027-11-29
Completion date2032-01-05→2032-05-21
Start dateestimated 2024-10-28→confirmed 2024-10-30
Study sites0→8
2024-08-02
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT06541704
Lead Sponsor Regeneron Pharmaceuticals
Conditions Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
Enrollment 975 participants
Start Date 2024-10-30
Primary Completion 2028-07-31 (estimated)
Study Completion 2033-04-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-18