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.
- Diseases
- Macular degeneration
- 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
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Augenzentrum Prof. Dr. Koch GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Augenzentrum Am St Franziskus-Hospital Muenster Coordinator of this site? Confirm its status | Munster | Germany | Recruiting |
| Diakonie Klinikum Dietrich Bonhoeffer GmbH Coordinator of this site? Confirm its status | Neubrandenburg | Germany | Recruiting |
| Knappschaftsklinikum Saar GmbH Coordinator of this site? Confirm its status | Sulzbach | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Institut Catala De Retina S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Centro De Oftalmologia Barraquer S.A. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Instituto De Microcirugia Ocular Dos S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Oftalmologia Vistahermosa S.L. Coordinator of this site? Confirm its status | Burjassot | Spain | Recruiting |
| Metavision Arruzafa S.L. Coordinator of this site? Confirm its status | Cordoba | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital La Luz Grupo Quironsalud Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Consorci Sanitari de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Fundacion Aiken De La Comunitat Valenciana Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Pole Vision Val d'Ouest Coordinator of this site? Confirm its status | Écully | France | Recruiting |
| Hôpital Privé La Louviere Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hopital De La Croix-Rousse Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Recruiting |
| Centre Monticelli Paradis d'Ophtalmologie Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Clinique Mathilde Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CHU de Toulouse - Hôpital Pierre-Paul Riquet Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Budapest Retina Associates Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Nozologen Kft. Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Multimedica S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| OFTALMIKA Sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Klinika Okulistyczna Jasne Blonia sp. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Caminomed Sp. z o.o. Coordinator of this site? Confirm its status | Tarnowskie Góry | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.