Clinical trial • Phase III • Ophthalmology

ANX007 for Dry age-related macular degeneration with geographic atrophy

Phase III trial of ANX007 for Dry age-related macular degeneration with geographic atrophy.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Dry age-related macular degeneration with geographic atrophy
Trial Stage
Phase III
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
03-10-2024
First CTIS Authorization Date
10-02-2025

Trial design

Randomised, anx007 arm: anx007 once em for 24 months (24 doses); sham arm: sham injection em for 24 months-controlled Phase III trial in Netherlands, Poland, Hungary and others.

Randomised
Yes
Comparator
ANX007 arm: ANX007 once EM for 24 months (24 doses); Sham arm: Sham injection EM for 24 months
Target Sample Size
505
Trial Duration For Participant
730

Eligibility

Recruits 505 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be adults (minimum age 50) and "Capable of giving signed informed consent" (principal inclusion criterion 8). Consent is provided by the participant; no paediatric assent procedures are described in the available documents..

Pregnancy Exclusion
7. A female participant is eligible if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) (defined as having undergone surgical sterilization or being postmenopausal [ie, greater than 50 years old with amenorrhea for at least 12 months without an alternative medical cause]). OR o Is a WOCBP using an acceptable contraceptive method during the study intervention period and for at least 30 days after the last dose of study intervention. • WOCBP must have a negative pregnancy test (PT) within 24 hours before the first dose of study intervention. • The Investigator has reviewed medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be adults (minimum age 50) and "Capable of giving signed informed consent" (principal inclusion criterion 8). Consent is provided by the participant; no paediatric assent procedures are described in the available documents.

Inclusion criteria

  • {"criterion_text":"- 1.\tFellow eyes treated with an approved anti-complement drug or other locally-administered treatment for GA that was initiated at least 4 weeks prior to randomization may continue treatment with no washout. Fellow eyes treated with an approved therapy for GA for fewer than 4 weeks should not be randomized in the study. GA -treatment-naive fellow eyes should, in the opinion of the Investigator, be unlikely to need treatment for GA in the fellow eye for at least the first year of the study.\n- 2.\tParticipant must be at least 50 years of age at the time of signing the informed consent.\n- 3.\t Able and willing to participate in a 24-month study with monthly visits.\n- 4.\tDiagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.\n- 5. The GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening. If both eyes are confirmed to be eligible by the independent Central Reading Center, the determination of the study eye selection is in the opinion of the Investigator. a.\tWell-demarcated GA with a total area (baseline lesion size) ≥2.5 mm2 and ≤ 17.5 mm2. b.\tIf GA is multifocal, at least one focal lesion must measure ≥1.25 mm2 with the overall aggregate area of GA as specified above in 5a. c.\tPresence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (ie., pattern = none) is exclusionary. d.\tThe entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.\n- 6.\tNormal luminance BCVA of 45 to 83 letters using ETDRS methodology(20/25 to 20/100 Snellen equivalent, inclusive). a.\t[CCI]\n- 7.\tA female participant is eligible if she is not pregnant or breastfeeding, and one of the following conditions applies: o\tIs a woman of non-childbearing potential (WONCBP) (defined as having undergone surgical sterilization or being postmenopausal [ie, greater than 50 years old with amenorrhea for at least 12 months without an alternative medical cause]). OR o\tIs a WOCBP using an acceptable contraceptive method during the study intervention period and for at least 30 days after the last dose of study intervention. •\tWOCBP must have a negative pregnancy test (PT) within 24 hours before the first dose of study intervention. •\tThe Investigator has reviewed medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n- 8.\tCapable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- 1.\tGeographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (eg, plaquenil maculopathy) in either eye.\n- 10.\tHistory of idiopathic, autoimmune-associated, or other uveitis in either eye.\"\n- 11.\tAny current or prior ocular condition, other than dry AMD with GA, that in the opinion of the Investigator could interfere with the conduct of the study (including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye).\n- 12.\tHistory of any prior IVT treatment for any indication in the study eye.\n- 13.\tAny prior treatment for AMD in the study eye ( including investigational treatments, eg, pharmacological, surgical, radiation, thermotherapeutic, light therapy, or laser intervention), or systemic anti-GA or anti-complement treatment (including investigational treatments). NOTE: Oral supplements (multivitamins/minerals, eg, AREDS vitamins) are permitted during the study.\n- 14.\tPrevious participation in any studies of investigational medications not already prohibited by Exclusions 12 and 13, within 3 months or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment.\n- 15.\tKnown hypersensitivity to ANX007 or any of the excipients in the ANX007 solution (as described in the ANX007 Investigator’s Brochure or other ANX molecules (eg ANX005).\n- 16.\tKnown hypersensitivity to fluorescein\n- 17.\tActive alcohol or substance abuse/dependence or any other reason that makes it unlikely that the participant will comply with study procedures.\n- 18.\tHistory of current systemic medical or psychiatric conditions or any other reason, including laboratory findings, that may, in the opinion of the Investigator, contraindicate the use of an investigational medication, affect interpretation of study results, preclude adherence to the study visit schedule, or safe participation in the study.\n- 2.\tAny evidence of CNV in the study eye: a.\tAny history of CNV of any cause based on medical history. b.\tEvidence of prior or active CNV or related findings (eg, retinal pigment epithelial rips or tears) based on FAF, SD-OCT imaging, intravenous fluorescein angiography (IVFA), and color fundus photo as assessed by the Central Reading Center.\n- 3.\tSpherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.\n- 4.\tUncontrolled glaucoma in the study eye (Intraocular pressure (IOP) >25 mmHg despite treatment with anti-glaucoma medication) or history of neovascular glaucoma.\n- 5.\tHistory of incisional glaucoma surgery (eg, glaucoma filtration surgery, minimally invasive glaucoma surgery implantation of a drainage device); vitrectomy surgery; or other procedure in the study eye that could affect drug distribution and/or clearance.\n- 6.\tHistory of cataract surgery less than 3 months prior to dosing in the study eye (cataract surgery should have been uncomplicated to be considered eligible).\n- 7.\tAny ophthalmic condition that may require surgery during the study period in the study eye\n- 8.\tOcular trauma in the study eye within the preceding 6 months.\n- 9.\tAny active ocular/intraocular infection or inflammation in either eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Confirmed best corrected visual acuity (BCVA) ≥15-letter loss from baseline through Month 15 as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) method.","definition_or_measurement_approach":"Assessed by the ETDRS method; endpoint is confirmed ≥15-letter loss from baseline through Month 15 on BCVA."}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of ocular and systemic treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI)","definition_or_measurement_approach":"Safety assessment via recording incidence and severity of ocular and systemic TEAEs and AESIs as reported during the study period."}

Recruitment

Registry Or Advocacy Recruitment
True, Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Planned Sample Size
505
Recruitment Window Months
35
Consent Approach
Participants must provide signed informed consent themselves (criterion 8). Multiple country-specific ICFs are provided (languages and country-specific ICF documents available for Dutch, Polish, Hungarian, French, Italian, German, Czech, Spanish, English, etc.). Special ICFs exist for pregnancy-related information, imaging certification, genetic testing, optional future research and reimbursement where applicable. No assent procedures are described (adults only).

Methods

  • Country-specific recruitment arrangements documents and 'Dear Patient' recruitment letters (documents present for multiple countries incl. NL, PL, HU, FR, IT, AT, DE, CZ, ES) — channel: mailed/clinic letters to potential patients; target audience: patients with dry AMD/GA.
  • GP-letter (Italy) — channel: general practitioner/GP communication to refer potential participants; target audience: primary care physicians in Italy.
  • Patient cards and site-level recruitment materials (documents titled Patient Card, Recruitment Procedure) — channel: printed materials at clinics; target audience: clinic patients.
  • Imaging certification / volunteer participant ICF documents — channel: site-based invitation for imaging volunteers; target audience: volunteers/patients for imaging certification procedures.

Geography

Total Number Of Sites
55
Total Number Of Participants
125

Netherlands

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
440
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Ophthalmology
Contact Person Name
Janneke van Lith-Verhoeven
Contact Person Email
j.vanlith-verhoeven@etz.nl

Poland

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
445
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Oftalmika Sp. z o.o.
Contact Person Name
Bartlomiej Kaluzny
Contact Person Email
bartka@by.onet.pl
Site Name
Osrodek Chirurgii Oka Prof.Zagorskiego Sp. z o.o.
Contact Person Name
Justyna Mazur- Samela
Contact Person Email
jsamela@ocho.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddzial Okulistyki Dorosłych
Contact Person Name
Ewa Mrukwa- Kominek
Contact Person Email
mrukwa@uck.katowice.pl
Site Name
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
Contact Person Name
Dominik Zalewski
Contact Person Email
domizal@gmail.com
Site Name
Caminomed Sp. z o.o.
Contact Person Name
Barbara Zatorska
Contact Person Email
caminomed.zatorska@gmail.com
Site Name
Warszawski Szpital Okulistyczny Sp. z o.o.
Contact Person Name
Agnieszka Nowosielska
Contact Person Email
nowosielska.aga@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
450
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Nozologen Kft.
Contact Person Name
Balázs Varsányi
Contact Person Email
varsanyi.balazs@ganglion.hu
Site Name
Semmelweis University
Contact Person Name
András Papp
Contact Person Email
andras.papp.md@gmail.com
Site Name
University Of Debrecen
Department Name
Szemklinika
Contact Person Name
Attila Vajas
Contact Person Email
vajasa@gmail.com
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Szemészeti Osztály
Contact Person Name
Vogt Gábor
Contact Person Email
gabor.vogt@tosho.hu
Site Name
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department Name
Szemészeti Osztály
Contact Person Name
Ágnes Kerényi
Contact Person Email
agneskerenyi@gmail.com
Site Name
Budapest Retina Associates Kft.
Department Name
Szemészeti Osztály
Contact Person Name
András Seres
Contact Person Email
seres@budapestretina.hu

France

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
479
Number Of Sites
10
Number Of Participants
8

Sites

Site Name
Pole Vision Val D'Ouest
Contact Person Name
Flore De Bats
Contact Person Email
gonzalez_flore@yahoo.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Ophthalmology Department
Contact Person Name
Stéphanie Baillif
Contact Person Email
Baillif.s@chu-nice.fr
Site Name
Centre Monticelli Paradis D Ophtalmologie
Department Name
Ophtalmologie
Contact Person Name
François Devin
Contact Person Email
fdbm.retine@gmail.com
Site Name
Ophtalmologie Maison Rouge S.C.M.
Department Name
Ophthalmology Department
Contact Person Name
Benjamin Wolff
Contact Person Email
bwolff@hotmail.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Ophthalmology Department
Contact Person Name
Aude Couturier
Contact Person Email
Aude.couturier@aphp.fr
Site Name
Quinze-Vingts National Ophthalmology Hospital
Department Name
Centre d ’Investigation Clinique 1423
Contact Person Name
Jean François Girmens
Contact Person Email
jfgirmens@15-20.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Ophthalmology Department
Contact Person Name
Catherine Creuzot-Garcher
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Ophthalmology Department
Contact Person Name
Marie-Noëlle Delyfer
Site Name
Hospices Civils De Lyon
Department Name
Ophtalmologie
Contact Person Name
Laurent Kodjikian
Contact Person Email
laurent.kodjikian@chu-lyon.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Ophthalmology Department
Contact Person Name
Eric Souied
Contact Person Email
eric.souied@chicreteil.fr

Austria

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
06-04-2026
Processing Time Days
446
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Department of Ophthalmology and Optometry
Contact Person Name
Yosuf El-Shabrawi
Contact Person Email
yosuf.el-shabrawi@kabeg.at
Site Name
Johannes Kepler University Linz
Department Name
Kepler University Clinic Linz, University Clinic for Ophthalmology and Optometry
Contact Person Name
Matthias Bolz

Italy

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
442
Number Of Sites
9
Number Of Participants
39

Sites

Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
U.O.C Retina Medica
Contact Person Name
Monica Varano
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Unit Patologie Retiniche - 4° piano - Torre 6
Contact Person Name
Federico Ricci
Contact Person Email
federico.ricci@uniroma2.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oculistica
Contact Person Name
Angelo Maria Minnella
Site Name
Careggi University Hospital
Department Name
SOD Oculistica
Contact Person Name
Daniela Bacherini
Contact Person Email
daniela.bacherini@unifi.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Operativa di Oculistica - Settore A / Piano -1
Contact Person Name
Francesco Bandello
Contact Person Email
bandello.francesco@hsr.it
Site Name
Multimedica S.p.A.
Department Name
U.O. Oculistica
Contact Person Name
Stela Vujosevic
Contact Person Email
stela.vujosevic@unimi.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Clinica Oculistica
Contact Person Name
Chiara Rosina
Contact Person Email
chiararosina@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Oculistica - Padiglione Regina Elena
Contact Person Name
Francesco Viola
Contact Person Email
francesco.viola@unimi.it
Site Name
Unit not otherwise specified

Czechia

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
449
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Oční klinika
Contact Person Name
Bohdan Kousal
Contact Person Email
bohdan.kousal@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Oftalmologická klinika
Contact Person Name
Jan Hamouz
Contact Person Email
hamouz@gmail.com
Site Name
Axon Clinical s.r.o.
Contact Person Name
Jan Ernest
Contact Person Email
jan.ernest@axon-clinical.com

Spain

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
449
Number Of Sites
13
Number Of Participants
27

Sites

Site Name
Hospital Universitario Miguel Servet
Department Name
Ophtalmology
Contact Person Name
Luis Pablo Julvez
Contact Person Email
lpablo@unizar.es
Site Name
Metavision Arruzafa S.L.
Department Name
Ophtalmology
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcubero@hospitalarruzafa.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Ophtalmology
Contact Person Name
Estanislao Gutierrez Sanchez
Contact Person Email
esgusan@hotmail.com
Site Name
Bellvitge University Hospital
Department Name
Ophtalmology
Contact Person Name
Luis Arias Barquet
Contact Person Email
larias@bellvitgehospital.cat
Site Name
Valles Ophthalmology Research S.L.
Department Name
Ophtalmology
Contact Person Name
Laura Sararols Ramsay
Contact Person Email
lsararols@omiq.es
Site Name
Clinica Baviera S.A.
Department Name
Ophtalmology
Contact Person Name
Marta Suarez de Figueroa
Contact Person Email
figueroa.marta@outlook.es
Site Name
Oftalmologia Vistahermosa S.L.
Department Name
Ophtalmology
Contact Person Name
Roberto Gallego Pinazo
Contact Person Email
robertogallegopinazo@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Ophtalmology
Contact Person Name
María Isabel Fernández Rodríguez
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Ophtalmology
Contact Person Name
Francisco Javier Ascaso Puyuelo
Contact Person Email
jascaso@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Ophtalmology
Contact Person Name
Miguel Angel Zapata Victori
Site Name
Institut Catala De Retina S.L.
Department Name
Ophtalmology
Contact Person Name
Ignasi Jürgens Mestre
Contact Person Email
Ignasi.jurgens@icrcat.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Ophtalmology
Contact Person Name
Jose Maria Ruiz Moreno
Contact Person Email
josemaria.ruiz@uclm.es
Site Name
Hospital Universitario Virgen De La Macarena (duplicate listing placeholder)

Germany

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
444
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department für Ophthalmologie
Contact Person Name
Victor Augustin
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Contact Person Name
Albrecht Lommatzsch
Site Name
Diakonie Klinikum Dietrich Bonhoeffer GmbH
Department Name
Klinik für Augenheilkunde
Contact Person Name
Christian Karl Brinkmann
Contact Person Email
BrinkmannC@dbknb.de
Site Name
Universitaetsklinikum Bonn AöR
Contact Person Name
Frank Holz
Contact Person Email
frank.holz@ukbonn.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department für Augenheilkunde
Contact Person Name
Felix Reichel

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Development LP
Responsibilities
Sponsor operational responsibilities (multiple sponsorDuties codes present in the record)
Name
Icon Public Limited Company
Responsibilities
Pharmacovigilance/SAE reporting

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC/RTSM","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Specialty lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Visual Acuity Certification","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Duke University","duties_or_roles":"reading center","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":"central lab","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"Specialty lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"Pharmacovigilance/SAE reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Multiple operational responsibilities (sponsorDuties codes present)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"Clinical Outcome Assessment provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Transportation/reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
ANX007
Active Substance
ANX007
Modality
Other antibody
Routes Of Administration
Intravitreal injection
Route
Intravitreal
Authorisation Status
Investigational (clinical trial)
Frequency
Monthly for 24 months

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