Clinical trial • Phase III • Ophthalmology

POZELIMAB for Geographic atrophy secondary to age-related macular degeneration

Phase III trial of POZELIMAB for Geographic atrophy secondary to age-related macular degeneration.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Geographic atrophy secondary to age-related macular degeneration
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Oligonucleotide
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
17-02-2025

Trial design

Randomised, placebo-controlled: placebo for pozelimab (aqueous buffered solution) and placebo for cemdisiran (0.9% saline) supplied by the sponsor; study compares subcutaneously administered pozelimab in combination with cemdisiran versus cemdisiran alone (placebo control arms are provided). dose and schedule not specified in the ctis record. Phase III trial across 81 sites in Italy, Spain, Austria and others.

Randomised
Yes
Comparator
Placebo-controlled: Placebo for pozelimab (aqueous buffered solution) and placebo for cemdisiran (0.9% saline) supplied by the sponsor; study compares subcutaneously administered pozelimab in combination with cemdisiran versus cemdisiran alone (placebo control arms are provided). Dose and schedule not specified in the CTIS record.
Target Sample Size
511

Eligibility

Recruits 511 No vulnerable population selected. The study population is restricted to adults. Informed consent is required from adult participants; assent is not applicable..

Vulnerable Population
No vulnerable population selected. The study population is restricted to adults. Informed consent is required from adult participants; assent is not applicable.

Inclusion criteria

  • {"criterion_text":"- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n- Total GA area in the study eye measuring between ≥2.5 mm^2 and ≤17.5 mm^2 as described in the protocol\n- BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol\n- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n- 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"}

Exclusion criteria

  • {"criterion_text":"- GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n- 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\n- Systemic Exclusion criteria: Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n- Systemic Exclusion criteria: Carrier of Neisseria meningitidis based on culture collected during screening\n- Systemic Exclusion criteria: Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply\n- History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n- 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\n- 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\n- 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\n- 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\n- Systemic Exclusion criteria: History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n- Systemic Exclusion criteria: History of solid organ or bone marrow transplantation\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Growth rate (slope) of total GA lesion area (mm^2 /year) measured by Fundus Autofluorescence (FAF)","definition_or_measurement_approach":"Growth rate (slope) of total geographic atrophy (GA) lesion area measured in mm^2 per year using Fundus Autofluorescence (FAF) imaging"}

Secondary endpoints

  • {"endpoint_text":"- Loss of Best Corrected Visual Acuity (BCVA) ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS)\n- Change in Low-contrast quantitative Visual Acuity (LC-qVA)\n- Change in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)\n- Change in quantitative Contrast Sensitivity Function (qCSF)\n- Growth rate (slope) of total GA lesion area (mm^2 /year) measured by FAF\n- Concentrations of total pozelimab in serum\n- Concentrations of total cemdisiran in plasma\n- Change in concentration of total Complement component 5 (C5)\n- Incidence of Antidrug antibody (ADA) to pozelimab\n- Magnitude of ADA to pozelimab\n- Incidence of ADA to cemdisiran\n- Magnitude of ADA to cemdisiran\n- Incidence of Neutralizing antibody (NAb) to pozelimab\n- Occurrence of Treatment-emergent adverse events (TEAEs)\n- Severity of TEAEs","definition_or_measurement_approach":"Endpoints include functional vision measures (BCVA ETDRS letter loss, LC-qVA, LL-LC-qVA, qCSF), imaging-based GA lesion growth measured by FAF (mm^2/year), pharmacokinetic measures of pozelimab and cemdisiran (serum/plasma concentrations), complement C5 concentration changes, immunogenicity endpoints (ADA and NAb incidence and magnitude) and safety endpoints (occurrence and severity of TEAEs). Specific measurement methods indicated in protocol: ETDRS charts for BCVA, FAF imaging for lesion area, and standard assays for PK and immunogenicity."}

Recruitment

Registry Or Advocacy Recruitment
True - Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia | Fundacion Aiken De La Comunitat Valenciana
Planned Sample Size
511
Recruitment Window Months
88
Consent Approach
Informed consent is obtained from adult participants using country-specific main ICFs. Submitted ICF documents include main and supplementary consent forms (pre-screening ICF, photo ICF, PGx ICF, future research/biobank ICF, optional TEP/TEP ICFs) and country-specific versions (e.g., Italy, Spain, Austria, Poland, France, Hungary). Consent is provided by the participant (adults); assent is not applicable.

Geography

Total Number Of Sites
81
Total Number Of Participants
464

Italy

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
338
Number Of Sites
11
Number Of Participants
56

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
380001: Oculistica
Principal Investigator Name
Francesco Bandello
Principal Investigator Email
bandello.francesco@hsr.it
Contact Person Name
Francesco Bandello
Contact Person Email
bandello.francesco@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
UC-2184001: PO San Giovanni di Dio
Principal Investigator Name
Enrico Peiretti
Principal Investigator Email
epeiretti@unica.it
Contact Person Name
Enrico Peiretti
Contact Person Email
epeiretti@unica.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
380007: Dip. Chirurgico, SC Oculistica
Principal Investigator Name
Francesco Viola
Principal Investigator Email
francesco.viola@unimi.it
Contact Person Name
Francesco Viola
Contact Person Email
francesco.viola@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
380009: UOC Oculistica
Principal Investigator Name
Stanislao Rizzo
Principal Investigator Email
stanislao.rizzo@gmail.com
Contact Person Name
Stanislao Rizzo
Contact Person Email
stanislao.rizzo@gmail.com
Site Name
Multimedica S.p.A.
Department Name
380008: U.O. Oculistica
Principal Investigator Name
Stela Vujosevic
Principal Investigator Email
stela.vujosevic@gmail.com
Contact Person Name
Stela Vujosevic
Contact Person Email
stela.vujosevic@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
380010: UO Oftalmologia Ciardella Dipartimento Testa collo e organi di senso
Principal Investigator Name
Antonio Pasquale Ciardella
Principal Investigator Email
antonio.ciardella@aosp.bo.it
Contact Person Name
Antonio Pasquale Ciardella
Contact Person Email
antonio.ciardella@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
380003: S.O.D. Clinica Oculistica
Principal Investigator Name
Marco Lupidi
Principal Investigator Email
marco.lupidi@ospedaliriuniti.marche.it
Contact Person Name
Marco Lupidi
Site Name
ASST Fatebenefratelli Sacco
Department Name
380006: SC Oculistica
Principal Investigator Name
Giovanni Staurenghi
Principal Investigator Email
giovanni.staurenghi@unimi.it
Contact Person Name
Giovanni Staurenghi
Contact Person Email
giovanni.staurenghi@unimi.it
Site Name
Azienda Ospediera Policlinico Universitario Tor Vergata
Department Name
380005: UNIT Patologie Retiniche
Principal Investigator Name
Federico Ricci
Principal Investigator Email
rccfrc00@gmail.com
Contact Person Name
Federico Ricci
Contact Person Email
rccfrc00@gmail.com
Site Name
Careggi University Hospital
Department Name
380002: SOD Ottica fisiopatologica
Principal Investigator Name
Gianni Virgili
Principal Investigator Email
gianni.virgili@unifi.it
Contact Person Name
Gianni Virgili
Contact Person Email
gianni.virgili@unifi.it
Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
380004: UOS Retina Medica
Principal Investigator Name
Mariacristina Parravano
Contact Person Name
Mariacristina Parravano

Spain

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
326
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Institut Catala De Retina S.L.
Department Name
724007: Oftalmología
Principal Investigator Name
Ignasi Jurgens Mestre
Principal Investigator Email
ijurgens@uic.es
Contact Person Name
Ignasi Jurgens Mestre
Contact Person Email
ijurgens@uic.es
Site Name
Oftalmologia Vistahermosa S.L.
Department Name
724009: Oftalmología
Principal Investigator Name
Roberto Gallego-Pinazo
Principal Investigator Email
robertogallegopinazo@gmail.com
Contact Person Name
Roberto Gallego-Pinazo
Contact Person Email
robertogallegopinazo@gmail.com
Site Name
Hospital La Luz Grupo Quironsalud
Department Name
724013: Oftalmología
Principal Investigator Name
Juan Donate López
Principal Investigator Email
juan.donate@amqoftalmos.es
Contact Person Name
Juan Donate López
Contact Person Email
juan.donate@amqoftalmos.es
Site Name
Centro De Oftalmologia Barraquer S.A.
Department Name
724011: Oftalmología
Principal Investigator Name
Santiago Abengoechea Hernandez
Principal Investigator Email
sah@barraquer.com
Contact Person Name
Santiago Abengoechea Hernandez
Contact Person Email
sah@barraquer.com
Site Name
Instituto De Microcirugia Ocular Dos S.L.
Department Name
724001: Oftalmología
Principal Investigator Name
Anniken Burés Jelstrup
Principal Investigator Email
anniken.bures@imo.es
Contact Person Name
Anniken Burés Jelstrup
Contact Person Email
anniken.bures@imo.es
Site Name
Hospital Universitario Miguel Servet
Department Name
724008: Oftalmología
Principal Investigator Name
Luis Emilio Pablo Julvez
Principal Investigator Email
lpablo@unizar.es
Contact Person Name
Luis Emilio Pablo Julvez
Contact Person Email
lpablo@unizar.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
724005: Oftalmología
Principal Investigator Name
Francisco Javier Ascaso Puyuelo
Principal Investigator Email
jascaso@gmail.com
Contact Person Name
Francisco Javier Ascaso Puyuelo
Contact Person Email
jascaso@gmail.com
Site Name
Consorci Sanitari De Terrassa
Department Name
724012: Ophthalmology
Principal Investigator Name
Gloria Biarge Gallardo
Principal Investigator Email
gbiarge@cst.cat
Contact Person Name
Gloria Biarge Gallardo
Contact Person Email
gbiarge@cst.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
724006: Oftalmología
Principal Investigator Name
Estanislao Gutiérrez Sánchez
Contact Person Name
Estanislao Gutiérrez Sánchez
Site Name
Fundacion Aiken De La Comunitat Valenciana
Department Name
724010: Oftalmología
Principal Investigator Name
Patricia Udaondo Mirete
Principal Investigator Email
draudaondo@gmail.com
Contact Person Name
Patricia Udaondo Mirete
Contact Person Email
draudaondo@gmail.com
Site Name
Metavision Arruzafa S.L.
Department Name
724002: Oftalmología
Principal Investigator Name
Juan Manuel Cubero Parra
Principal Investigator Email
jmcp@hospitalarruzafa.com
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcp@hospitalarruzafa.com
Site Name
Bellvitge University Hospital
Department Name
724004: Oftalmología
Principal Investigator Name
Luis Arias Barquet
Principal Investigator Email
larias@bellvitgehospital.cat
Contact Person Name
Luis Arias Barquet
Contact Person Email
larias@bellvitgehospital.cat

Austria

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
337
Number Of Sites
3
Number Of Participants
42

Sites

Site Name
Medical University Of Graz
Department Name
040002: Universitäts-Augenklinik
Principal Investigator Name
Monja Michelitsch
Principal Investigator Email
monja.michelitsch@medunigraz.at
Contact Person Name
Monja Michelitsch
Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
040001: 1. Medizinische Abteilung
Principal Investigator Name
Oliver Findl
Principal Investigator Email
oliver@findl.at
Contact Person Name
Oliver Findl
Contact Person Email
oliver@findl.at
Site Name
Medical University Of Vienna
Department Name
040003: Universitätsklinik für Augenheilkunde und Optometrie
Principal Investigator Name
Stefan Sacu
Principal Investigator Email
stefan.sacu@meduniwien.ac.at
Contact Person Name
Stefan Sacu
Contact Person Email
stefan.sacu@meduniwien.ac.at

Germany

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
360
Number Of Sites
17
Number Of Participants
140

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
276016
Principal Investigator Name
Victor Augustin
Principal Investigator Email
victor.augustin@med.uni-heidelberg.de
Contact Person Name
Victor Augustin
Site Name
Knappschaftsklinikum Saar GmbH
Department Name
276014: Augenklinik Sulzbach
Principal Investigator Name
Boris Stanzel
Principal Investigator Email
boris.stanzel@kksaar.de
Contact Person Name
Boris Stanzel
Contact Person Email
boris.stanzel@kksaar.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
276007
Principal Investigator Name
Kristina Pfau
Principal Investigator Email
Kristina.pfau@ukbonn.de
Contact Person Name
Kristina Pfau
Contact Person Email
Kristina.pfau@ukbonn.de
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Department Name
276012: Augenklinik
Principal Investigator Name
Georg Spital
Principal Investigator Email
georg.spital@augen-franziskus.de
Contact Person Name
Georg Spital
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
276011: Klinik für Augenheilkunde
Principal Investigator Name
Walter Sekundo
Principal Investigator Email
sekundo@staff.uni-marburg.de
Contact Person Name
Walter Sekundo
Contact Person Email
sekundo@staff.uni-marburg.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
276013: Klinik und Poliklinik für Augenheilkunde
Principal Investigator Name
Martin Spitzer
Principal Investigator Email
m.spitzer@uke.de
Contact Person Name
Martin Spitzer
Contact Person Email
m.spitzer@uke.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
276004: Augenklinik
Principal Investigator Name
Rainer Guthoff
Principal Investigator Email
rainer.guthoff@med.uni-duesseldorf.de
Contact Person Name
Rainer Guthoff
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
276008: Klinik für Augenheilkunde
Principal Investigator Name
Antonia M. Joussen
Principal Investigator Email
antonia.joussen@charite.de
Contact Person Name
Antonia M. Joussen
Contact Person Email
antonia.joussen@charite.de
Site Name
Universitaetsmedizin Goettingen
Department Name
276001: Klinik für Augenheilkunde
Principal Investigator Name
Sebastian Bemme
Principal Investigator Email
sebastian.bemme@med.uni-goettingen.de
Contact Person Name
Sebastian Bemme
Site Name
Diakonie Klinikum Dietrich Bonhoeffer GmbH
Department Name
276002: Augenheilkunde
Principal Investigator Name
Christian Brinkmann
Principal Investigator Email
BrinkmannC@dbknb.de
Contact Person Name
Christian Brinkmann
Contact Person Email
BrinkmannC@dbknb.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
276018: Klinik und Poliklinik für Augenheilkunde
Principal Investigator Name
Andreas Berlin
Principal Investigator Email
berlin_a@ukw.de
Contact Person Name
Andreas Berlin
Contact Person Email
berlin_a@ukw.de
Site Name
Augenzentrum Prof. Dr. Koch GmbH
Department Name
276017: Augenklinik
Principal Investigator Name
Frank H.J. Koch
Principal Investigator Email
koch@augenzentrumfrankfurt.de
Contact Person Name
Frank H.J. Koch
Contact Person Email
koch@augenzentrumfrankfurt.de
Site Name
Universitaet Des Saarlandes
Department Name
276010
Principal Investigator Name
Berthold Seitz
Principal Investigator Email
berthold.seitz@uks.eu
Contact Person Name
Berthold Seitz
Contact Person Email
berthold.seitz@uks.eu
Site Name
Universitaetsklinikum Ulm AöR
Department Name
276015: Augenklinik
Principal Investigator Name
Armin Wolf
Principal Investigator Email
Armin.Wolf@uniklinik-ulm.de
Contact Person Name
Armin Wolf
Contact Person Email
Armin.Wolf@uniklinik-ulm.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
276003: Klinik für Augenheilkunde
Principal Investigator Name
Nicole Eter
Principal Investigator Email
direktorin.augenklinik@ukmuenster.de
Contact Person Name
Nicole Eter
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
276006: Augenklinik
Principal Investigator Name
Lars-Olof Hattenbach
Principal Investigator Email
hattenbach.studien@klilu.de
Contact Person Name
Lars-Olof Hattenbach
Contact Person Email
hattenbach.studien@klilu.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
276009: Augenklinik und Poliklinik
Principal Investigator Name
Katrin Lorenz
Principal Investigator Email
katrin.lorenz@unimedizin-mainz.de
Contact Person Name
Katrin Lorenz

Poland

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
332
Number Of Sites
11
Number Of Participants
40

Sites

Site Name
Oftalmika Sp. z o.o.
Department Name
616003: Ophtalmology
Principal Investigator Name
Bartlomiej Kaluzny
Principal Investigator Email
bartka@by.onet.pl
Contact Person Name
Bartlomiej Kaluzny
Contact Person Email
bartka@by.onet.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
616007: Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Principal Investigator Name
Bozena Romanowska-Dixon
Principal Investigator Email
bozenakania@cm-uj.krakow.pl
Contact Person Name
Bozena Romanowska-Dixon
Contact Person Email
bozenakania@cm-uj.krakow.pl
Site Name
Szpital Swietego Lukasza S.A.
Department Name
616005: Poradnia Okulistyczna
Principal Investigator Name
Bogumil Wowra
Principal Investigator Email
bogumilwowra@gmail.com
Contact Person Name
Bogumil Wowra
Contact Person Email
bogumilwowra@gmail.com
Site Name
Caminomed Sp. z o.o.
Department Name
616002: Ophtalmology
Principal Investigator Name
Wojciech Jedrzejewski
Principal Investigator Email
caminomed.jedrzejewski@gmail.com
Contact Person Name
Wojciech Jedrzejewski
Site Name
Klinika Okulistyczna Jasne Blonia Sp. z o.o.
Department Name
616008: Ophtalmology
Principal Investigator Name
Zofia Nawrocka
Principal Investigator Email
zosia_n@yahoo.com
Contact Person Name
Zofia Nawrocka
Contact Person Email
zosia_n@yahoo.com
Site Name
Osrodek Chirurgii Oka Prof.Zagorskiego Sp. z o.o.
Department Name
616004: Ophtalmology
Principal Investigator Name
Justyna Mazur-Samela
Principal Investigator Email
justynamazursamela@gmail.com
Contact Person Name
Justyna Mazur-Samela
Contact Person Email
justynamazursamela@gmail.com
Site Name
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
Department Name
616002: Ophtalmology
Principal Investigator Name
Dominik Zalewski
Principal Investigator Email
domizal@gmail.com
Contact Person Name
Dominik Zalewski
Contact Person Email
domizal@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
616001: Klinika Okulistyki
Principal Investigator Name
Joanna Adamiec-Mroczek
Principal Investigator Email
j.adamiec@wp.pl
Contact Person Name
Joanna Adamiec-Mroczek
Contact Person Email
j.adamiec@wp.pl
Site Name
Osrodek Chirurgii Oka Prof.Zagorskiego Sp. z o.o.
Department Name
616004: Ophtalmology
Site Name
Additional listed Polish site
Site Name
Additional listed Polish site

France

Earliest CTIS Part Ii Submission Date
20-01-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
421
Number Of Sites
16
Number Of Participants
95

Sites

Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
250012: Service d’Ophtalmologie
Principal Investigator Name
Jean-Claude Quintyn
Principal Investigator Email
quintyn-jc@chu-caen.fr
Contact Person Name
Jean-Claude Quintyn
Contact Person Email
quintyn-jc@chu-caen.fr
Site Name
CHU de Toulouse - Hôpital Pierre-Paul Riquet
Department Name
250011: Service d'Ophtalmologie
Principal Investigator Name
Vincent SOLER
Principal Investigator Email
soler.v@chu-toulouse.fr
Contact Person Name
Vincent SOLER
Contact Person Email
soler.v@chu-toulouse.fr
Site Name
Hospital Hotel Dieu
Department Name
250004: Ophtalmologie
Principal Investigator Name
Hélène Massé
Principal Investigator Email
helene.masse@chu-nantes.fr
Contact Person Name
Hélène Massé
Contact Person Email
helene.masse@chu-nantes.fr
Site Name
Centre Monticelli Paradis D Ophtalmologie
Department Name
250002
Principal Investigator Name
François Devin
Principal Investigator Email
fr.devin@numericable.fr
Contact Person Name
François Devin
Contact Person Email
fr.devin@numericable.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
250005: Service Ophtalmologie
Principal Investigator Name
Eric Souied
Principal Investigator Email
eric.souied@chicreteil.fr
Contact Person Name
Eric Souied
Contact Person Email
eric.souied@chicreteil.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
250010: Service d'Ophtalmologie
Principal Investigator Name
Aude Couturier
Principal Investigator Email
aude.couturier@lrb.aphp.fr
Contact Person Name
Aude Couturier
Contact Person Email
aude.couturier@lrb.aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
250007: Service Ophtalmologie
Principal Investigator Name
Catherine Creuzot-Garcher
Principal Investigator Email
catherine.creuzot-garcher@chu-dijon.fr
Contact Person Name
Catherine Creuzot-Garcher
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
250009: Service d'Ophtalmologie
Principal Investigator Name
Nicolas Leveziel
Principal Investigator Email
nicolas.leveziel@chu-poitiers.fr
Contact Person Name
Nicolas Leveziel
Site Name
Clinique Mathilde
Department Name
250006: Service Ophtalmologie
Principal Investigator Name
Joel Uzzan
Principal Investigator Email
jo.uzzan.oph@gmail.com
Contact Person Name
Joel Uzzan
Contact Person Email
jo.uzzan.oph@gmail.com
Site Name
Hopital Saint Joseph
Department Name
250014: Service d'Ophtalmologie
Principal Investigator Name
Frederic Queguiner
Principal Investigator Email
fqueguiner@hopital-saint-joseph.fr
Contact Person Name
Frederic Queguiner
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
250001: Ophthalmology
Principal Investigator Name
Stéphanie Baillif-Gostoli
Principal Investigator Email
baillif.s@chu-nice.fr
Contact Person Name
Stéphanie Baillif-Gostoli
Contact Person Email
baillif.s@chu-nice.fr
Site Name
Hopital Prive La Louviere
Department Name
250008: Ophtalmologie
Principal Investigator Name
Stephane Dumas
Principal Investigator Email
stephanedumas@nordretine.fr
Contact Person Name
Stephane Dumas
Contact Person Email
stephanedumas@nordretine.fr
Site Name
Pole Vision Val D'Ouest
Department Name
250013
Principal Investigator Name
Flore DeBats
Principal Investigator Email
flore.debats@chu-lyon.fr
Contact Person Name
Flore DeBats
Contact Person Email
flore.debats@chu-lyon.fr
Site Name
Hopital De La Croix-Rousse
Department Name
250003: Ophtalmologie
Principal Investigator Name
Laurent Kodjikian
Principal Investigator Email
laurent.kodjikian@chu-lyon.fr
Contact Person Name
Laurent Kodjikian
Contact Person Email
laurent.kodjikian@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
250007: Service Ophtalmologie
Site Name
Additional listed French site

Hungary

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
469
Number Of Sites
11
Number Of Participants
46

Sites

Site Name
Semmelweis University
Department Name
348001
Principal Investigator Name
András Papp
Principal Investigator Email
andras.papp.md@gmail.com
Contact Person Name
András Papp
Contact Person Email
andras.papp.md@gmail.com
Site Name
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Department Name
348004
Principal Investigator Name
György Bátor
Principal Investigator Email
bator.gyorgy@markusovszky.hu
Contact Person Name
György Bátor
Contact Person Email
bator.gyorgy@markusovszky.hu
Site Name
Nozologen Kft.
Department Name
348003
Principal Investigator Name
Balázs Varsányi
Principal Investigator Email
varsanyi.balazs@ganglion.hu
Contact Person Name
Balázs Varsányi
Contact Person Email
varsanyi.balazs@ganglion.hu
Site Name
Budapest Retina Associates Kft.
Department Name
348002
Principal Investigator Name
András Seres
Principal Investigator Email
seres@budapestretina.hu
Contact Person Name
András Seres
Contact Person Email
seres@budapestretina.hu
Site Name
University Of Szeged
Department Name
348007
Principal Investigator Name
Edit Tóth-Molnár
Principal Investigator Email
tme@tmedit.hu
Contact Person Name
Edit Tóth-Molnár
Contact Person Email
tme@tmedit.hu
Site Name
University Of Debrecen
Department Name
348006
Principal Investigator Name
Attila Vajas
Principal Investigator Email
vajasa@gmail.com
Contact Person Name
Attila Vajas
Contact Person Email
vajasa@gmail.com
Site Name
Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
Department Name
#NA: Szemészeti Osztály
Principal Investigator Name
Norbert Czumbel
Principal Investigator Email
czumbel@gmail.com
Contact Person Name
Norbert Czumbel
Contact Person Email
czumbel@gmail.com
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
348008: Szemészet
Principal Investigator Name
Gábor Vogt
Principal Investigator Email
gabor.vogt@tosho.hu
Contact Person Name
Gábor Vogt
Contact Person Email
gabor.vogt@tosho.hu
Site Name
Additional listed Hungarian site
Site Name
Additional listed Hungarian site
Site Name
Additional listed Hungarian site

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Central Labs
Responsibilities
Central laboratory functions (sponsor duties code: 4)
Name
Charles River Laboratories Montreal ULC
Responsibilities
Laboratory services (sponsor duties code: 4)
Name
QPS LLC
Responsibilities
Laboratory/assay services (sponsor duties code: 4)
Name
Perceptive Informatics Inc.
Responsibilities
Data/analytics related duties (sponsor duties code: 3)
Name
Clario Medical Imaging Inc.
Responsibilities
ECG Central Reader

Third parties

  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Renibus Ireland Limited","duties_or_roles":"Patient engagement","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Adaptive Sensory Technology GmbH","duties_or_roles":"Collection of secondary endpoints","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"University Of Wisconsin","duties_or_roles":"DMC services","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Study Logos and branding","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Duke University","duties_or_roles":"Central reading center, support imaging based I/E criteria, stratification, Primary endpoint","organisation_type":"Educational Institution"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Certifications","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"ECG Central Reader","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Pozelimab
Active Substance
POZELIMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous use
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised (prodAuthStatus: 1)
Investigational Product Name
Cemdisiran
Active Substance
CEMDISIRAN
Modality
Oligonucleotide
Routes Of Administration
Subcutaneous injection
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised (prodAuthStatus: 1)
Orphan Designation
Yes
Combination Treatment
Yes

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