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

Last updated: August 28, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neoplasm Metastasis

Macular Degeneration

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

    Site Not Available

  • Strathfield Retina Clinic

    Strathfield, New South Wales 2135
    Australia

    Site Not Available

  • Sydney Eye Hospital

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Strathfield Retina Clinic

    Strathfield 2148088, New South Wales 2155400 2135
    Australia

    Site Not Available

  • Sydney Eye Hospital

    Sydney 2147714, New South Wales 2155400 2000
    Australia

    Site Not Available

  • Sydney Retina Clinic and Day Surgery

    Sydney 2147714, New South Wales 2155400 2000
    Australia

    Site Not Available

  • Centre For Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Retina Specialists Victoria

    Rowville, Victoria 3178
    Australia

    Site Not Available

  • Centre For Eye Research Australia

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Beijing Hospital of Ministry of Health

    Beijing, 100730
    China

    Site Not Available

  • 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 Hospital of Ministry of Health

    Beijing 1816670, 100730
    China

    Site Not Available

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing 1816670, 100730
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing 1816670, 102218
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, 100730
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing City, 102218
    China

    Site Not Available

  • 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

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun 2038180, 130041
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou City, 510060
    China

    Site Not Available

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, 150001
    China

    Site Not Available

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin 2037013, 150001
    China

    Site Not Available

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 265299
    China

    Site Not Available

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao 1797929, 265299
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • Eye & ENT Hospital of Fudan University

    Shanghai 1796236, 200030
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai 1796236, 200080
    China

    Site Not Available

  • Eye & ENT Hospital of Fudan University

    Shanghai City, 200030
    China

    Site Not Available

  • First Hospital of China Medical University

    Shenyang, 110001
    China

    Site Not Available

  • First Hospital of China Medical University

    Shenyang 2034937, 110001
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan 1793511, 030002
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan City, 030002
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin 1792947, 300070
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin City, 300070
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou 1791388, 325027
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou City, 325027
    China

    Site Not Available

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

    Wuhan,
    China

    Site Not Available

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

    Wuhan 1791247,
    China

    Site Not Available

  • Wuxi No.2 People's Hospital

    Wuxi, 214000
    China

    Site Not Available

  • Wuxi No.2 People's Hospital

    Wuxi 1790923, 214000
    China

    Site Not Available

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

    XI An,
    China

    Site Not Available

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

    Xi'an 1790630,
    China

    Site Not Available

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

    Xi'an City, 710004
    China

    Site Not Available

  • Chi De Creteil

    Creteil, 94010
    France

    Site Not Available

  • Chi De Creteil; Ophtalmologie

    Creteil, 94010
    France

    Active - Recruiting

  • Chi De Creteil

    Créteil 3022530, 94010
    France

    Site Not Available

  • Pole Vision Val d'Ouest

    Ecully, 69130
    France

    Site Not Available

  • Pole Vision Val d'Ouest; Ophtalmologie

    Ecully, 69130
    France

    Active - Recruiting

  • Hopital de la croix rousse

    Lyon 2996944, 69317
    France

    Site Not Available

  • Hopital de la croix rousse

    Lyon cedex, 69317
    France

    Site Not Available

  • Hopital de la croix rousse; Ophtalmologie

    Lyon cedex, 69317
    France

    Active - Recruiting

  • Centre Paradis Monticelli

    Marseille, 13008
    France

    Site Not Available

  • Centre Paradis Monticelli; Ophtalmologie

    Marseille, 13008
    France

    Active - Recruiting

  • Centre Paradis Monticelli

    Marseille 2995469, 13008
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu; Ophthalmology

    Nantes, 44093
    France

    Active - Recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes 2990969, 44093
    France

    Site Not Available

  • CHNO des Quinze Vingts

    Paris, 75012
    France

    Site Not Available

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012
    France

    Active - Recruiting

  • Hopital Lariboisiere

    Paris, 75010
    France

    Site Not Available

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010
    France

    Active - Recruiting

  • Fondation Rothschild

    Paris 2988507, 75940
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris 2988507, 75010
    France

    Site Not Available

  • Fondation Rothschild

    Paris Cedex 19, 75940
    France

    Site Not Available

  • Fondation Rothschild; Ophtalmologie

    Paris Cedex 19, 75940
    France

    Active - Recruiting

  • Centres Ophtalmologique St Exupéry

    Saint-Cyr-sur-Loire 2980935, 37540
    France

    Site Not Available

  • Centres Ophtalmologique St Exupéry

    St Cyr Sur Loire, 37540
    France

    Site Not Available

  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    St Cyr Sur Loire, 37540
    France

    Active - Recruiting

  • Centre Ophtalmologique Maison-Rouge

    Strasbourg, 67000
    France

    Site Not Available

  • Universitätsklinikum Köln

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau 2925177, 79106
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075
    Germany

    Site Not Available

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

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Köln; Augenklinik

    Köln, 50937
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149
    Germany

    Active - Recruiting

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280
    Germany

    Site Not Available

  • Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach

    Sulzbach, 66280
    Germany

    Active - Recruiting

  • Knappschaftsklinikum Saar GmbH

    Sulzbach 2824841, 66280
    Germany

    Site Not Available

  • Queen Mary Hospital; Department of Ophthalmology

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • The University of Hong Kong

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Hong Kong Eye Hospital

    Mong Kok 1819353,
    Hong Kong

    Site Not Available

  • Hong Kong Eye Hospital

    Mongkok,
    Hong Kong

    Site Not Available

  • Hong Kong Eye Hospital; CUHK Eye Centre

    Mongkok,
    Hong Kong

    Active - Recruiting

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo 66100
    Italy

    Site Not Available

  • Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

    Chieti, Abruzzo 66100
    Italy

    Active - Recruiting

  • Ospedale Clinicizzato SS Annunziata

    Chieti 3178796, Abruzzo 3183560 66100
    Italy

    Site Not Available

  • Policlinico di Bari

    Bari 3182351, Apulia 3169778 70124
    Italy

    Site Not Available

  • Ospedale Monaldi - AORN dei Colli

    Napoli, Campania 80131
    Italy

    Site Not Available

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

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Ospedale Monaldi - AORN dei Colli

    Napoli 9031661, Campania 3181042 80131
    Italy

    Site Not Available

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

    Roma, Lazio 00184
    Italy

    Site Not Available

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

    Rome 3169070, Lazio 3174976 00184
    Italy

    Site Not Available

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

    Milano, Lombardia 20100
    Italy

    Site Not Available

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

    Milano, Lombardia 20100
    Italy

    Active - Recruiting

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

    Milan 3173435, Lombardy 3174618 20100
    Italy

    Site Not Available

  • Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Policlinico di Bari; U.O. Oftalmologia Universitaria

    Bari, Puglia 70124
    Italy

    Active - Recruiting

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

    Udine, Veneto 33100
    Italy

    Active - Recruiting

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

    Udine, Veneto 3164604 33100
    Italy

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kim's Eye Hospital

    Seoul, 07301
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • 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

  • OFTALMIKA Sp. z o.o

    Bydgoszcz 3102014, 85-631
    Poland

    Site Not Available

  • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

    Gliwice, 44-100
    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

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice 3096472, 40-594
    Poland

    Site Not Available

  • Centrum Medyczne UNO-MED

    Krakow, 31-070
    Poland

    Site Not Available

  • Centrum Medyczne UNO-MED

    Krakow 3094802, 31-070
    Poland

    Site Not Available

  • Gabinet Okulistyczny Jerzy Mackiewicz

    Lublin, 20-064
    Poland

    Site Not Available

  • Gabinet Okulistyczny Jerzy Mackiewicz

    Lublin 765876, 20-064
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn 763166, 10-424
    Poland

    Site Not Available

  • 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

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • National University Hospital; Ophthalmology Department

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Singapore Eye Research Institute

    Singapore, 168751
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital; Ophthalmology Department

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Asia Pacific Eye Centre

    Singapore 1880252, 258500
    Singapore

    Site Not Available

  • National University Hospital

    Singapore 1880252, 119074
    Singapore

    Site Not Available

  • Singapore Eye Research Institute

    Singapore 1880252, 168751
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore 1880252, 308433
    Singapore

    Site Not Available

  • Yeungnam University Medical Center

    Daegu 1835329, 42415
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Kim's Eye Hospital

    Seoul 1835848, 07301
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hospital Universitario de Bellvitge

    L' Hospitalet DE Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat 3120619, Barcelona 08907
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna 15706
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela 3109642, LA Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Instituto de microcirugia ocular

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Cordoba, 14012
    Spain

    Site Not Available

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Córdoba 2519240, 14012
    Spain

    Site Not Available

  • Oftalvist

    Madrid, 28006
    Spain

    Site Not Available

  • Oftalvist; Servicio de oftalmologia

    Madrid, 28006
    Spain

    Active - Recruiting

  • Oftalvist

    Madrid 3117735, 28006
    Spain

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital; Ophthalmology

    New Taipei City, 220
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City 12908892, 220
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital; Ophthalmology

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital; Ophthalmology

    Zhongzheng Dist., 10002
    Taiwan

    Active - Recruiting

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