A Phase 3 interventional study of Pozelimab and Cemdisiran in Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), sponsored by Regeneron Pharmaceuticals. Recruiting at 233 sites in 11 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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:
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's planned enrollment of 975 is above the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Compared within Geographic Atrophy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Macular Degeneration. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
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
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized 1:1:1
Drug: Pozelimab · Drug: Cemdisiran
Randomized 1:1:1
Drug: Cemdisiran
Randomized 1:1:1
Drug: Placebo
Subcutaneous (SC) injection
Also known as: REGN3918
SC injection
Also known as: ALN-CC5
SC injection
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)
Time frame: To week 52
Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline
Time frame: At week 52 and week 104
Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA)
Time frame: At week 52 and week 104
Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)
Time frame: At week 52 and week 104
Change from baseline in quantitative Contrast Sensitivity Function (qCSF)
Time frame: At week 52 and week 104
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF
Time frame: To week 104
Concentrations of total pozelimab in serum
Time frame: Through week 52 and through week 104
Concentrations of total cemdisiran in plasma
Time frame: Through week 52 and through week 104
Change from baseline in concentration of total Complement component 5 (C5)
Time frame: Through week 52 and through week 104
Incidence of Antidrug antibody (ADA) to pozelimab
Time frame: Through week 52 and through week 104
Magnitude of ADA to pozelimab
Time frame: Through week 52 and through week 104
Incidence of ADA to cemdisiran
Time frame: Through week 52 and through week 104
Magnitude of ADA to cemdisiran
Time frame: Through week 52 and through week 104
Incidence of Neutralizing Antibody (NAb) to pozelimab
Time frame: Through week 52 and through week 104
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through week 52, 104, 140 and week 296
Severity of TEAEs
Time frame: Through week 52, 104, 140 and week 296
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Showing the first 100 of 233 sites across 11 countries. Choose a country and city above to see the rest.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy.
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Cemdisiran