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New drug faricimab takes on leading cause of blindness in nearsighted people

NCT ID NCT06176352

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tested a drug called faricimab (VABYSMO®) against an existing treatment (ranibizumab) for people with vision loss caused by abnormal blood vessels growing in the back of the eye due to severe nearsightedness. The trial involved 280 participants who received either faricimab or ranibizumab as an eye injection, with additional treatments as needed. The main goal was to see if faricimab could improve or maintain eyesight as well as the current standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
faricimab (VABYSMO®)
What this could lead to
If successful, faricimab could offer a new treatment option for people with vision loss due to severe nearsightedness, potentially improving or stabilizing eyesight.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not prove superior to the existing treatment (ranibizumab), and eye injections carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

280 people

The number who actually took part.

Started

Mar 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia 2. Diagnosis of active myopic CNV in the study eye: 1. Presence of high myopia, worse than -6 diopters of spherical equivalence 2. Antero-posterior elongation measurement greater than or equal to 26.0 mm 3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.) 4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\]) 5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC) 3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1 4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests 5. Ability to comply with the study protocol, in the Investigator's judgment 6. Other protocol-defined inclusion criteria apply 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 or within 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 prior to Day 1 5. History of systemic or ocular disease that would contraindicate treatment with the investigational 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 in study eye 8. Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye 9. Other protocol-defined exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

choroidal neovascularization degenerative myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Choroidal neovascularization secondary to pathologic myopia

Contacts and locations

Locations

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

    Udine, Veneto, 33100, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asia Pacific Eye Centre

    Singapore, 258500, Singapore

  • Beijing Hospital of Ministry of Health

    Beijing, 100730, China

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, 100730, China

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218, China

  • CHU Nantes - Hotel Dieu

    Nantes, 44093, France

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

    Wuhan, China

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Centre Paradis Monticelli

    Marseille, 13008, France

  • Centres Ophtalmologique St Exupéry

    Saint-Cyr-sur-Loire, 37540, France

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424, Poland

  • Centrum Medyczne UNO-MED

    Krakow, 31-070, Poland

  • Chi De Creteil

    Créteil, 94010, France

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706, Spain

  • Eye & ENT Hospital of Fudan University

    Shanghai, 200030, China

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027, China

  • Far Eastern Memorial Hospital

    New Taipei City, 220, Taiwan

  • First Hospital of China Medical University

    Shenyang, 110001, China

  • Fondation Rothschild

    Paris, 75940, France

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

    Rome, Lazio, 00184, Italy

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

    Milan, Lombardy, 20100, Italy

  • Gabinet Okulistyczny Jerzy Mackiewicz

    Lublin, 20-064, Poland

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594, Poland

  • Hong Kong Eye Hospital

    Mong Kok, Hong Kong

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hopital de la croix rousse

    Lyon, 69317, France

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012, Spain

  • Kim's Eye Hospital

    Seoul, 07301, South Korea

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

    Lódz, 91-134, Poland

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280, Germany

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631, Poland

  • Oftalvist

    Madrid, 28006, Spain

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100, Italy

  • Ospedale Monaldi - AORN dei Colli

    Naples, Campania, 80131, Italy

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 265299, China

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai First People's Hospital

    Shanghai, 200080, China

  • Shanxi Eye Hospital

    Taiyuan, 030002, China

  • Singapore Eye Research Institute

    Singapore, 168751, Singapore

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135, Australia

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, 150001, China

  • The Second Hospital of Jilin University

    Changchun, 130041, China

  • The University of Hong Kong

    Hong Kong, Hong Kong

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070, China

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106, Germany

  • Wuxi No.2 People's Hospital

    Wuxi, 214000, China

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

    Xi'an, China

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060, China

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