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New eye drug could cut wet AMD shots to just twice a year

NCT ID NCT06795048

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This study tests whether faricimab, an already-approved eye injection, can be given every 24 weeks (about twice a year) to people newly diagnosed with wet age-related macular degeneration (AMD). The trial involves 274 participants and will measure how well vision is maintained over 100 weeks. If it works, it could greatly reduce the burden of frequent eye injections for patients.

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) eye injection
What this could lead to
If successful, this could allow people with wet AMD to receive treatment only twice a year instead of monthly, while maintaining or improving vision.
What could go wrong
This is a phase 4 study, so faricimab is already approved. However, not all patients may respond well to the extended dosing, 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 274 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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

50 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: * Overtly healthy as determined by medical evaluation that includes medical history and physical examination * Agreement to adhere to the contraception requirements described in the protocol Ocular Inclusion Criteria for Study Eye: * Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT) * BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1) * Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis Exclusion Criteria: Ocular Exclusion Criteria for Study Eye: * MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis * Retinal pigment epithelial tear involving the macula on Day 1 * Current vitreous hemorrhage on Day 1 * Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases Ocular Exclusion Criteria for Fellow (Non-Study) Eye: * Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits Ocular Exclusion for Both Eyes: * History of idiopathic or autoimmune associated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

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

Neovascular age-related macular degeneration (NAMD)

Contacts and locations

Locations

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000, Australia

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Augenzentrum Prof. Koch GmbH

    Frankfurt, 60549, Germany

  • Augenzentrum am St Franziskus-Hospital

    Münster, Germany

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica

    Napoli, Sicily, 80138, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette - Ancona, The Marches, 60126, Italy

  • Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica

    Rome, Lazio, 00189, Italy

  • Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica

    Foggia, Apulia, 71122, Italy

  • Cardiff and Vale University Health Board

    Cardiff, CF14 4XW, United Kingdom

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Centre Ophtalmologique de L'Odeon

    Paris, 75006, France

  • Centre Retine Gallien

    Bordeaux, 33000, France

  • Centres Ophtalmologique St Exupéry

    Saint-Cyr-sur-Loire, 37540, France

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • China Medical University Hospital

    Taichung, 404332, Taiwan

  • Clinica Baviera

    Madrid, 28046, Spain

  • Clinique de l'Union

    Saint-Jean, 31240, France

  • Ctr for Retina & Macular Dis

    Winter Haven, Florida, 33880, United States

  • Eye and ENT hospital, Fudan University

    Shanghai, China

  • Florida Retina Institute

    Orlando, Florida, 32806-1101, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69437, France

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • Hospital General de Catalunya

    Sant Cugat de Valles, Barcelona, 08190, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP, United Kingdom

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hanover, 30625, Germany

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD, United Kingdom

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002, Taiwan

  • New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • New England Retina Consultants

    Springfield, Massachusetts, 01107, United States

  • NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Oftalvist

    Burjassot, Valencia(España), Valencia, 46100, Spain

  • Orange County Retina Medical Group

    Santa Ana, California, 92705, United States

  • Ospedale San Giuseppe

    Milan, Lombardy, 20123, Italy

  • Peking University People's Hospital

    Beijing, 100044, China

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Retina Associates of New Jersey

    Teaneck, New Jersey, 07666, United States

  • Retina Consultants of Texas

    Schertz, Texas, 78154, United States

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Specialists Victoria

    Rowville, Victoria, 3178, Australia

  • Retinal Vitreal Consultants

    Chicago, Illinois, 60616, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Sierra Eye Associates

    Sparks, Nevada, 89434, United States

  • Singapore Eye Research Institute

    Singapore, 168751, Singapore

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St. Joseph's Health Care

    London, Ontario, N6A 4V2, Canada

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135, Australia

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009, Australia

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030, China

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9, Canada

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • Universitatsklinikum Ulm, Augenklinik und Poliklinik

    Ulm, 89075, Germany

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439, United States

  • Universitätsklinikum Würzburg, Augenklinik und Poliklinik

    Würzburg, 97080, Germany

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060, China

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Other studies related to the condition(s) this trial covers.