A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Last updated: April 10, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Neoplasm Metastasis

Myopia

Treatment

Faricimab

Sham Procedure

Ranibizumab

Clinical Study ID

NCT06176352
CR44829
2023-506707-25-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia

  2. Diagnosis of active myopic CNV in the study eye:

  3. Presence of high myopia, worse than -6 diopters of spherical equivalence

  4. Antero-posterior elongation measurement greater than or equal to 26.0 mm

  5. Presence of posterior changes compatible with pathologic myopia (e.g.,tessellated fundus, lacquer cracks, etc.)

  6. Presence of active leakage from CNV on FFA (determined by Central ReadingCentre [CRC])

  7. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)

  8. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellenequivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocolon Day 1

  9. Overtly healthy as determined by medical evaluation that includes medical history,physical examination, and laboratory tests

  10. Ability to comply with the study protocol, in the Investigator's judgment

  11. Other protocol-defined inclusion criteria apply

Exclusion

Exclusion Criteria:

  1. Any major illness or major surgical procedure within 1 month before screening

  2. Pregnancy or breastfeeding, or intention to become pregnant during the study orwithin 3 months after the final study treatment administration

  3. Uncontrolled blood pressure (systolic >180 millimetres of mercury [mmHg], diastolic >100 mmHg)

  4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months priorto Day 1

  5. History of systemic or ocular disease that would contraindicate treatment with theinvestigational drug or comparator

  6. Uncontrolled glaucoma in study eye

  7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities,including, but not restricted to, intravitreal, periocular or laser interventions instudy eye

  8. Prior or concomitant periocular or intravitreal pharmacological treatment, includinganti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DMEetc.) in study eye

  9. Other protocol-defined exclusion criteria apply

Study Design

Total Participants: 280
Treatment Group(s): 3
Primary Treatment: Faricimab
Phase: 3
Study Start date:
March 06, 2024
Estimated Completion Date:
April 21, 2026

Connect with a study center

  • South West Retina

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Strathfield Retina Clinic

    Strathfield, New South Wales 2135
    Australia

    Active - Recruiting

  • Sydney Eye Hospital

    Sydney, New South Wales 2000
    Australia

    Active - Recruiting

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales 2000
    Australia

    Active - Recruiting

  • Centre For Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Retina Specialists Victoria

    Rowville, Victoria 3178
    Australia

    Active - Recruiting

  • Beijing Hospital of Ministry of Health

    Beijing, 100730
    China

    Active - Recruiting

  • Beijing Hospital of Ministry of Health; ophthalmology department

    Beijing, 100730
    China

    Active - Recruiting

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing City, 102218
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing City, 100730
    China

    Site Not Available

  • Peking Union Medical College Hospital; Pharmacy

    Beijing City, 100730
    China

    Active - Recruiting

  • The Second Hospital of Jilin University

    Changchun, 130041
    China

    Active - Recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou City, 510060
    China

    Active - Recruiting

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, 150001
    China

    Active - Recruiting

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 265299
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • Eye & ENT Hospital of Fudan University

    Shanghai City, 200030
    China

    Active - Recruiting

  • First Hospital of China Medical University

    Shenyang, 110001
    China

    Active - Recruiting

  • Shanxi Eye Hospital

    Taiyuan City, 030002
    China

    Active - Recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin City, 300070
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou City, 325027
    China

    Active - Recruiting

  • Central Theater General Hospital of the Chinese People's Liberation Army

    Wuhan,
    China

    Active - Recruiting

  • Wuxi No.2 People's Hospital

    Wuxi, 214000
    China

    Active - Recruiting

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    XI An,
    China

    Active - Recruiting

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an City, 710004
    China

    Site Not Available

  • Chi De Creteil

    Creteil, 94010
    France

    Active - Recruiting

  • Chi De Creteil; Ophtalmologie

    Creteil, 94010
    France

    Active - Recruiting

  • Pole Vision Val d'Ouest

    Ecully, 69130
    France

    Active - Recruiting

  • Pole Vision Val d'Ouest; Ophtalmologie

    Ecully, 69130
    France

    Active - Recruiting

  • Hopital de la croix rousse

    Lyon cedex, 69317
    France

    Active - Recruiting

  • Hopital de la croix rousse; Ophtalmologie

    Lyon cedex, 69317
    France

    Active - Recruiting

  • Centre Paradis Monticelli

    Marseille, 13008
    France

    Active - Recruiting

  • Centre Paradis Monticelli; Ophtalmologie

    Marseille, 13008
    France

    Active - Recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • CHU Nantes - Hôtel Dieu; Ophthalmology

    Nantes, 44093
    France

    Active - Recruiting

  • CHNO des Quinze Vingts

    Paris, 75012
    France

    Active - Recruiting

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012
    France

    Active - Recruiting

  • Hopital Lariboisiere

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010
    France

    Active - Recruiting

  • Fondation Rothschild

    Paris Cedex 19, 75940
    France

    Active - Recruiting

  • Fondation Rothschild; Ophtalmologie

    Paris Cedex 19, 75940
    France

    Active - Recruiting

  • Centres Ophtalmologique St Exupéry

    St Cyr Sur Loire, 37540
    France

    Active - Recruiting

  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    St Cyr Sur Loire, 37540
    France

    Active - Recruiting

  • Centre Ophtalmologique Maison-Rouge

    Strasbourg, 67000
    France

    Active - Recruiting

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln; Augenklinik

    Köln, 50937
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149
    Germany

    Active - Recruiting

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280
    Germany

    Active - Recruiting

  • Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach

    Sulzbach, 66280
    Germany

    Active - Recruiting

  • Queen Mary Hospital; Department of Ophthalmology

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Hong Kong Eye Hospital

    Mongkok,
    Hong Kong

    Active - Recruiting

  • Hong Kong Eye Hospital; CUHK Eye Centre

    Mongkok,
    Hong Kong

    Active - Recruiting

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo 66100
    Italy

    Active - Recruiting

  • Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

    Chieti, Abruzzo 66100
    Italy

    Active - Recruiting

  • Ospedale Monaldi - AORN dei Colli

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Ospedale Monaldi - AORN dei Colli; U.O.C. Oculistica

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Roma, Lazio 00184
    Italy

    Active - Recruiting

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

    Milano, Lombardia 20100
    Italy

    Active - Recruiting

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

    Milano, Lombardia 20100
    Italy

    Active - Recruiting

  • Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Active - Recruiting

  • Policlinico di Bari; U.O. Oftalmologia Universitaria

    Bari, Puglia 70124
    Italy

    Active - Recruiting

  • A.O. Universitaria S. Maria Della Misericordia Di Udine

    Udine, Veneto 33100
    Italy

    Active - Recruiting

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

    Udine, Veneto 33100
    Italy

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Kim's Eye Hospital

    Seoul, 07301
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.

    ?ód?, 91-134
    Poland

    Site Not Available

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631
    Poland

    Site Not Available

  • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

    Gliwice, 44-100
    Poland

    Site Not Available

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594
    Poland

    Site Not Available

  • Centrum Medyczne UNO-MED

    Krakow, 31-070
    Poland

    Site Not Available

  • Gabinet Okulistyczny Jerzy Mackiewicz

    Lublin, 20-064
    Poland

    Active - Recruiting

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424
    Poland

    Active - Recruiting

  • reOptis Sp. z o.o.

    Pozna?, 61-144
    Poland

    Site Not Available

  • LensClinic

    Rybnik, 44-203
    Poland

    Site Not Available

  • Asia Pacific Eye Centre

    Singapore, 258500
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • National University Hospital; Ophthalmology Department

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Singapore Eye Research Institute

    Singapore, 168751
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital; Ophthalmology Department

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    L' Hospitalet DE Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Instituto de microcirugia ocular

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Cordoba, 14012
    Spain

    Active - Recruiting

  • Oftalvist

    Madrid, 28006
    Spain

    Active - Recruiting

  • Oftalvist; Servicio de oftalmologia

    Madrid, 28006
    Spain

    Active - Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital; Ophthalmology

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital; Ophthalmology

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital; Ophthalmology

    Zhongzheng Dist., 10002
    Taiwan

    Active - Recruiting

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