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Eye drug faricimab under the microscope: Real-World data collection begins

NCT ID NCT06680817

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 08, 2026 · Updated 4 times

Summary

This study is collecting information from 850 people with wet age-related macular degeneration or diabetic macular edema who are being treated with faricimab (VABYSMO) in routine clinical practice. Over two years, researchers will track vision changes, treatment schedules, and safety. The goal is to understand how well the drug works in real-world settings and to gather insights that could help guide future treatment decisions.

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, this study could provide doctors with better insights on how to use faricimab in everyday practice, potentially improving treatment outcomes for people with wet AMD or diabetic macular edema.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection or varying treatment practices. It does not test a new drug or prove cause and effect.

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.

Participants

About 850 people

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

Started

Feb 2025

Expected to finish

Jun 2028

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.

Who is studied

Patients being treated with faricimab approved for nAMD and DME in real-world, routine clinical practice.

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: * Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye * Patients have received at least one faricimab treatment (the first dose) in the study eye * Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it) Exclusion Criteria: * Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date * Concomitant participation in any interventional clinical study * Active ocular inflammation and/or suspected/active ocular infection in either eye * Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP) * Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia) * Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)

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Conditions

The condition(s) this trial relates to.

diabetic macular edema wet macular degeneration

As listed by the trial registrant

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

Diabetic macular edema Neovascular age-related macular degeneration

Contacts and locations

Locations

  • Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology

    Varna, 9010, Bulgaria

  • Barzilai Medical Center

    Ashkelon, 7827800, Israel

  • Bon Secours Hospital, Limerick

    Limerick, V94 HE2T, Ireland

  • Carmel medical center

    Haifa, 3436212, Israel

  • Centrul Oftalmologic Dr. Munteanu

    Timișoara, Romania

  • Centrum Uslug Medycznych OKO-MED

    Grudziądz, 86-300, Poland

  • Clinica Bine

    Bucharest, Romania

  • ETZ Elisabeth

    Tilburg, 5022 GC, Netherlands

  • Erzsebet Furdo Gyogyaszati es Szurokozpont

    Miskolc, 3530, Hungary

  • Espaco Medico Coimbra

    Coimbra, 3030-163, Portugal

  • Eye Diseases Medical Center LUX OPTICS;ophthalmology

    Sofia, 1164, Bulgaria

  • Eye Medical Center St. Luka

    Plovdiv, 4002, Bulgaria

  • Faculty Hospital Ostrava

    Ostrava, 708 52, Czechia

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín, 911 71, Slovakia

  • Fakultna nemocnica Trnava

    Trnava, 917 75, Slovakia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • General Hospital Murska Sobota

    Murska Sobota, 9000, Slovenia

  • General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross

    Athens, 115 26, Greece

  • Hanusch Krankenhaus

    Vienna, 1140, Austria

  • Helsinki University Central Hospital

    Helsinki, 00290, Finland

  • Hospital CUF Tejo

    Lisbon, 1350-352, Portugal

  • Hospital de Sao Joao

    Porto, 4200-319, Portugal

  • IMO - Instituto de Microcirurgia Ocular

    Lisbon, 1600-209, Portugal

  • Institute of Eye Surgery

    Waterford, Ireland

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021, Austria

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    Mladá Boleslav, 293 50, Czechia

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63, Czechia

  • LKH-Univ.Klinikum Graz

    Graz, 8036, Austria

  • Latvian-American Eye Center

    Riga, 1009, Latvia

  • Mater Private Hospital

    Dublin, 7, Ireland

  • Medical Clinic Svetlina

    Sofia, Bulgaria

  • Medizinische Universitat Wien

    Vienna, 1090, Austria

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

    Plovdiv, 4000, Bulgaria

  • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

    Bielsk Podlaski, 17-100, Poland

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov, 075 01, Slovakia

  • OFTAL s.r.o. Specializovana nemocnica v odbore oftalmologia Zvolen

    Zvolen, 960 01, Slovakia

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29, Greece

  • Pauls Stradins Clinical University hospital

    Riga, 1002, Latvia

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7623, Hungary

  • Pomorski Uniwersytet Medyczny

    Szczecin, 70-111, Poland

  • Retina Clinic

    Bucharest, 14146, Romania

  • Riga East Clinical University hospital Bikernieki

    Riga, 1006, Latvia

  • Shaare Zedek Medical Center

    Jerusalem, 91031, Israel

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100, Israel

  • Soroka university medical center

    Beersheba, 8489501, Israel

  • Szegedi Tudományegyetem ÁOK

    Szeged, 6720, Hungary

  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

    Zielona Góra, 65-046, Poland

  • Szpital Wojewodzki w Poznaniu

    Poznan, 60-479, Poland

  • Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy

    Wejherowo, 84-200, Poland

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Tokuda Hospital

    Sofia, 1407, Bulgaria

  • ULS Lisboa Ocidental - Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • USK Nr 2 im. WAM w Lodzi, Centralny Szpital Weteranow

    Lodz, 90-549, Poland

  • University General Hospital of Heraklion

    Heraklion, 711 10, Greece

  • University Hospital of Larissa

    Larissa, 412 21, Greece

  • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

    Prague, 169 02, Czechia

  • Vista Vision

    Bucurescti, Romania

More trials for these conditions

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