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Looking for participantsPhase3

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

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT06541704

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pozelimab (drug), Cemdisiran (drug), Placebo (drug)
How long the study runs
Study runs about 102 months (dates as stated)
About the drug or intervention
Pozelimab — drug: Subcutaneous (SC) injection · Cemdisiran — drug: SC injection · Placebo — drug: SC injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 85 Years
Who
All
Number of participants
975
Started
2024-10-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for age-related macular degeneration (amd)
  • • Phase3 - 975 participants
  • • This study is researching experimental (study) drugs called pozelimab and cemdisiran

Who can take part?

  • • Ages 50 Years to 85 Years
  • • Diagnosed with age-related macular degeneration (amd)

Where?

  • • Liverpool - Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
  • • York - York and Scarborough Teaching Hospitals NHS Foundation Trust
  • • Bristol - University Hospitals Bristol NHS Foundation Trust
  • • London - Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

Age-related Macular Degeneration (AMD)Geographic Atrophy (GA)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 85 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ per protocol

What the study is looking for

  • ✓Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
  • ✓Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
  • ✓BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
  • ✓Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the...
  • ✓Willing and able to comply with clinic visits and study-related procedures, including completion of the full series...

Who cannot take part

  • ✗GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies...
  • ✗History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal...
  • ✗Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as...
  • ✗Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full...
  • ✗Systemic Exclusion criteria
See the full criteria
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

Where Is This Study? (6 UK sites)

Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology

Liverpool L7 8XP, United Kingdom

Recruiting

York and Scarborough Teaching Hospitals NHS Foundation Trust

York YP31 8HE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Lydia Harris

yhs-tr.research.governance@nhs.net01904 726606

University Hospitals Bristol NHS Foundation Trust

Bristol BS1 2LX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Diana Benton

research@uhbw.nhs.uk0117 342 0233

Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital

London EC1V 2PD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu

moorfields.resadmin@nhs.net0207 566 2036

Imperial College Healthcare NHS Trust

London NW1 5QH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE1 4LP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09