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NCT06541704RecruitingPhase 3

A study Investigating Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Adult Participants with Geographic Atrophy

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: EU CTIS (euclinicaltrials.eu) · Last updated 12 Jun 2026

Brief summary (registry, in English)

To evaluate the effect of systemic Complement Component 5 (C5) inhibition on Geographic atrophy (GA) lesion growth over 52 weeks

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
464 (estimated)
First submitted
11 Oct 2024
Start date
22 May 2025
Lead sponsor
Regeneron Pharmaceuticals Inc.
NCT number
NCT06541704
EU CT number
2023-509547-27-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 464
  • 70 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Systemic Exclusion criteria: 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
  • 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
  • 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
  • Systemic Exclusion criteria: History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
  • Systemic Exclusion criteria: 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

Other illness

  • GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
  • 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
  • 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: History of solid organ or bone marrow transplantation

Lab values

  • Systemic Exclusion criteria: Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol

Other

  • Systemic Exclusion criteria: Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
  • Systemic Exclusion criteria: Carrier of Neisseria meningitidis based on culture collected during screening
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
  • History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol

Who 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 study eye as described in the protocol
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Augenzentrum Prof. Dr. Koch GmbH
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Frankfurt am MainGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaet Des Saarlandes
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HomburgGermanyRecruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
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Ludwigshafen Am RheinGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Augenzentrum Am St Franziskus-Hospital Muenster
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MunsterGermanyRecruiting
Diakonie Klinikum Dietrich Bonhoeffer GmbH
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NeubrandenburgGermanyRecruiting
Knappschaftsklinikum Saar GmbH
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SulzbachGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Institut Catala De Retina S.L.
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BarcelonaSpainRecruiting
Centro De Oftalmologia Barraquer S.A.
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BarcelonaSpainRecruiting
Instituto De Microcirugia Ocular Dos S.L.
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BarcelonaSpainRecruiting
Oftalmologia Vistahermosa S.L.
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BurjassotSpainRecruiting
Metavision Arruzafa S.L.
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CordobaSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Hospital La Luz Grupo Quironsalud
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MadridSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Consorci Sanitari de Terrassa
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TerrassaSpainRecruiting
Fundacion Aiken De La Comunitat Valenciana
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ValenciaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Pole Vision Val d'Ouest
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ÉcullyFranceRecruiting
Hôpital Privé La Louviere
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LilleFranceRecruiting
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceRecruiting
Centre Monticelli Paradis d'Ophtalmologie
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MarseilleFranceRecruiting
Hôpital Saint Joseph
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MarseilleFranceRecruiting
Hospital Hotel Dieu
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 10FranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Clinique Mathilde
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RouenFranceRecruiting
CHU de Toulouse - Hôpital Pierre-Paul Riquet
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ToulouseFranceRecruiting
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
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BudapestHungaryRecruiting
Central Hospital Of Northern Pest Military Hospital
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Budapest VIHungaryRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Budapest Retina Associates Kft.
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Budapest XIIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Nozologen Kft.
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PécsHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
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SzombathelyHungaryRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Ospedaliero - Universitaria di Cagliari
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CagliariItalyRecruiting
Careggi University Hospital
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FlorenceItalyRecruiting
Multimedica S.p.A.
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
ASST Fatebenefratelli Sacco
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
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RomeItalyRecruiting
OFTALMIKA Sp. z o.o
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Klinika Okulistyczna Jasne Blonia sp. z o.o
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LodzPolandRecruiting
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
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OlsztynPolandRecruiting
Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
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RzeszówPolandRecruiting
Caminomed Sp. z o.o.
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Tarnowskie GóryPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.