A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

NCT ID: NCT06680817

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-05

Study Completion Date

2028-06-30

Brief Summary

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The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.

Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Faricimab for nAMD

This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.

Faricimab

Intervention Type DRUG

Faricimab will be administered as per local clinical practice and local labeling.

Cohort 2: Faricimab for DME

This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.

Faricimab

Intervention Type DRUG

Faricimab will be administered as per local clinical practice and local labeling.

Interventions

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Faricimab

Faricimab will be administered as per local clinical practice and local labeling.

Intervention Type DRUG

Other Intervention Names

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VABYSMO® RO6867461 RG7716

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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LKH-Univ.Klinikum Graz

Graz, , Austria

Site Status RECRUITING

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Kepler Universitätskliniken GmbH - Med Campus III

Linz, , Austria

Site Status RECRUITING

Medizinische Universitat Wien

Vienna, , Austria

Site Status RECRUITING

Hanusch Krankenhaus

Vienna, , Austria

Site Status RECRUITING

Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

Plovdiv, , Bulgaria

Site Status RECRUITING

Eye Medical Center St. Luka

Plovdiv, , Bulgaria

Site Status RECRUITING

Eye Diseases Medical Center LUX OPTICS;ophthalmology

Sofia, , Bulgaria

Site Status RECRUITING

Tokuda Hospital

Sofia, , Bulgaria

Site Status RECRUITING

Medical Clinic Svetlina

Sofia, , Bulgaria

Site Status RECRUITING

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

Varna, , Bulgaria

Site Status RECRUITING

Krajska nemocnice Liberec a.s.

Liberec, , Czechia

Site Status RECRUITING

Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

Mladá Boleslav, , Czechia

Site Status RECRUITING

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Faculty Hospital Ostrava

Ostrava, , Czechia

Site Status RECRUITING

Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

Prague, , Czechia

Site Status RECRUITING

Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

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

Athens, , Greece

Site Status RECRUITING

University General Hospital of Heraklion

Heraklion, , Greece

Site Status RECRUITING

University Hospital of Larissa

Larissa, , Greece

Site Status RECRUITING

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Erzsebet Furdo Gyogyaszati es Szurokozpont

Miskolc, , Hungary

Site Status RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Site Status RECRUITING

Szegedi Tudományegyetem ÁOK

Szeged, , Hungary

Site Status RECRUITING

Mater Private Hospital

Dublin, , Ireland

Site Status RECRUITING

Institute of Eye Surgery

Waterford, , Ireland

Site Status RECRUITING

Barzilai Medical Center

Ashkelon, , Israel

Site Status RECRUITING

Shamir Medical Center Assaf Harofeh

Beer Jacob, , Israel

Site Status RECRUITING

Soroka university medical center

Beersheba, , Israel

Site Status RECRUITING

Carmel medical center

Haifa, , Israel

Site Status RECRUITING

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Pauls Stradins Clinical University hospital

Riga, , Latvia

Site Status RECRUITING

Riga East Clinical University hospital Bikernieki

Riga, , Latvia

Site Status RECRUITING

Latvian-American Eye Center

Riga, , Latvia

Site Status RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

ETZ Elisabeth

Tilburg, , Netherlands

Site Status RECRUITING

NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

Bielsk Podlaski, , Poland

Site Status RECRUITING

Centrum Uslug Medycznych OKO-MED

Grudziądz, , Poland

Site Status RECRUITING

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

Lodz, , Poland

Site Status RECRUITING

Szpital Wojewodzki w Poznaniu

Poznan, , Poland

Site Status RECRUITING

Pomorski Uniwersytet Medyczny

Szczecin, , Poland

Site Status RECRUITING

Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy

Wejherowo, , Poland

Site Status RECRUITING

Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

Zielona Góra, , Poland

Site Status RECRUITING

Espaco Medico Coimbra

Coimbra, , Portugal

Site Status RECRUITING

ULS Lisboa Ocidental - Hospital Egas Moniz

Lisbon, , Portugal

Site Status RECRUITING

Hospital CUF Tejo

Lisbon, , Portugal

Site Status RECRUITING

IMO - Instituto de Microcirurgia Ocular

Lisbon, , Portugal

Site Status RECRUITING

Hospital de Sao Joao

Porto, , Portugal

Site Status RECRUITING

Nemocnica s poliklinikou Trebišov, a.s.

Trebišov, , Slovakia

Site Status RECRUITING

Fakultna nemocnica Trencin Ocna klinika

Trenčín, , Slovakia

Site Status RECRUITING

Fakultna nemocnica Trnava

Trnava, , Slovakia

Site Status RECRUITING

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

Zvolen, , Slovakia

Site Status RECRUITING

General Hospital Murska Sobota

Murska Sobota, , Slovenia

Site Status RECRUITING

Countries

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Austria Bulgaria Czechia Finland Greece Hungary Ireland Israel Latvia Netherlands Poland Portugal Slovakia Slovenia

Central Contacts

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Reference Study ID Number: MR45586 https://forpatients.roche.com/

Role: CONTACT

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

Other Identifiers

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MR45586

Identifier Type: -

Identifier Source: org_study_id