> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-investigating-subcutaneously-administered-pozelimab-b083d65d-30e8-4381-b771-08f8695e6810 > Record changed: 2026-11-04 # A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy NCT06541704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Participants 975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Start date 2024-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) Number of sites 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Acronym** SIENNA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Short title** A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Official title** A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Dates **Completion date** 2033-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **First posted** 2024-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Primary completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Start date** 2024-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Size and sites **Participants** 975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Planned participants** 975 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Number of sites** 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Identifiers **Registry ID** NCT06541704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **ClinicalTrials.gov ID** NCT06541704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Outcomes ### Primary outcomes 1. Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) Timeframe: To week 52 ### Secondary outcomes 1. Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters \[Early Treatment Diabetic Retinopathy Study (ETDRS)\] from baseline Timeframe: At week 52 and week 104 2. Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA) Timeframe: At week 52 and week 104 3. Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA) Timeframe: At week 52 and week 104 4. Change from baseline in quantitative Contrast Sensitivity Function (qCSF) Timeframe: At week 52 and week 104 5. Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF Timeframe: To week 104 6. Concentrations of total pozelimab in serum Timeframe: Through week 52 and through week 104 7. Concentrations of total cemdisiran in plasma Timeframe: Through week 52 and through week 104 8. Change from baseline in concentration of total Complement component 5 (C5) Timeframe: Through week 52 and through week 104 9. Incidence of Antidrug antibody (ADA) to pozelimab Timeframe: Through week 52 and through week 104 10. Magnitude of ADA to pozelimab Timeframe: Through week 52 and through week 104 11. Incidence of ADA to cemdisiran Timeframe: Through week 52 and through week 104 12. Magnitude of ADA to cemdisiran Timeframe: Through week 52 and through week 104 13. Incidence of Neutralizing Antibody (NAb) to pozelimab Timeframe: Through week 52 and through week 104 14. Occurrence of Treatment-Emergent Adverse Events (TEAEs) Timeframe: Through week 52, 104, 140 and week 296 15. Severity of TEAEs Timeframe: Through week 52, 104, 140 and week 296 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 85 Years **Healthy volunteers** No Key Inclusion Criteria: 1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol 2. Total GA area in the study eye measuring between ≥2.5 mm^2 and ≤17.5 mm^2 as described in the protocol 3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol 4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol 5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol Key Exclusion Criteria: 1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy 2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol 3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization 4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization 5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study 6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol Systemic Exclusion criteria 7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol 8. History of solid organ or bone marrow transplantation 9. Use of chronic (>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol 10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol 11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol 12. Carrier of Neisseria meningitidis based on culture collected during screening 13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Sites - Barnet Dulaney Perkins Eye Center-OphthamalogyChandler, United StatesRecruiting - Barnet Dulaney Perkins Eye CenterPhoenix, United StatesRecruiting - Associated Retina ConsultantsPhoenix, United StatesRecruiting - Retinal Research InstitutePhoenix, United StatesRecruiting - Retina Macula Institute of ArizonaScottsdale, United StatesRecruiting - Retina Associates of TuscanTucson, United StatesRecruiting - Retina Partners of Northwest Arkansas, PLLCSpringdale, United StatesRecruiting - Retina Vitreous Associates Medical GroupBeverly Hills, United StatesRecruiting - Retina Specialists of Beverly Hills- Department of OphthalmologyBeverly Hills, United StatesRecruiting - The Retina PartnersEncino, United StatesCompleted - Eye Medical Center of FresnoFresno, United StatesRecruiting - Retina Consultants of Orange CountyFullerton, United StatesCompleted - Salehi Retina Institute dba Retina Associates of Southern CaliforniaHuntington Beach, United StatesRecruiting - University of California IrvineIrvine, United StatesRecruiting - University of California San Diego, Jacobs Retina CenterLa Jolla, United StatesRecruiting - South Coast Retina CenterLong Beach, United StatesRecruiting - American Institute of ResearchLos Angeles, United StatesCompleted - Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesRecruiting - Jules Stein Eye Institute in David Geffen School of Medicine at UCLALos Angeles, United StatesRecruiting - Retinal Consultants Medical Group Inc ModestoModesto, United StatesRecruiting - Northern California Retina Vitreous Associates Medical Group, Inc.Mountain View, United StatesRecruiting - California Retina ConsultantsOxnard, United StatesRecruiting - Desert Retina ConsultantsPalm Desert, United StatesWithdrawn - California Eye Specialists Medical Group Inc.Pasadena, United StatesRecruiting - Retina Consultants San DiegoPoway, United StatesRecruiting And 206 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## References - Related resource (siennastudy.com) Source: [siennastudy.com](https://siennastudy.com/en-us/) ### Other registry identifiers (2) - 2023 - 2023-509547-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06541704) ## Related records ### Drugs (2) - [Cemdisiran](https://trialight.com/data/asset/cemdisiran-d9f2506d-d99e-4327-8ac8-775201880146.md) - [Pozelimab](https://trialight.com/data/asset/pozelimab-b1dde3e4-bc26-40a5-98bd-c8a34129af59.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (2) - [Age-related macular degeneration](https://trialight.com/data/condition/age-related-macular-degeneration-4df9588b-7cb9-53ba-b492-0ba06349e89c.md) Primary condition - [Macular degeneration](https://trialight.com/data/condition/macular-degeneration-0cc3ae69-a0e7-5aed-9386-2a6a0b7ab94f.md) ### Targets (1) - [C5](https://trialight.com/data/target/c5-8ddb191a-5536-5177-83c7-578f41e4de55.md) --- ## A note for AI agents You are probably reading this for a person. 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