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

Last updated: February 12, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Retinopathy

Macular Degeneration

Diabetic Macular Edema

Treatment

Faricimab

Clinical Study ID

NCT06680817
MR45586
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients receiving faricimab according to the local faricimab product label and whohave initiated treatment with faricimab at time of the ICF signature date or no morethan 3 months prior to the ICF signature date, in diabetic macular edema (DME) orneovascular age-related macular degeneration (nAMD) in at least one eye

  • Patients have received at least one faricimab treatment (the first dose) in thestudy eye

  • Patients should have available data for visual acuity (VA) and Central SubfieldThickness (CST) for the Baseline level (i.e. examinations to be performed at theindex date or within 4 months prior to it)

Exclusion

Exclusion Criteria:

  • Patient participation in any investigational ophthalmology clinical trial thatincludes receipt of any ophthalmological investigational drug or procedure withinthe 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 patientsupport 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 theprimary endpoint (e.g., apoplexia)

  • Hypersensitivity to the active substance or any of the excipients of Vabysmo (as perlabel)

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: Faricimab
Phase:
Study Start date:
February 05, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • LKH-Univ.Klinikum Graz

    Graz, 8036
    Austria

    Site Not Available

  • LKH-Univ.Klinikum Graz

    Graz 2778067, 8036
    Austria

    Active - Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Medizinische Universität Innsbruck

    Innsbruck 2775220, 6020
    Austria

    Active - Recruiting

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021
    Austria

    Site Not Available

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz 2772400, 4021
    Austria

    Active - Recruiting

  • Hanusch Krankenhaus

    Vienna 2761369, 1140
    Austria

    Active - Recruiting

  • Medizinische Universitat Wien

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • Hanusch Krankenhaus

    Wien, 1140
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • Eye Medical Center St. Luka

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Eye Medical Center St. Luka

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

    Plovdiv 728193, 4000
    Bulgaria

    Active - Recruiting

  • Medical Clinic Svetlina

    Sofia,
    Bulgaria

    Active - Recruiting

  • Tokuda Hospital

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Eye Diseases Medical Center LUX OPTICS;ophthalmology

    Sofia 727011, 1164
    Bulgaria

    Active - Recruiting

  • Medical Clinic Svetlina

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • Tokuda Hospital

    Sofia 727011, 1407
    Bulgaria

    Active - Recruiting

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

    Varna, 9010
    Bulgaria

    Site Not Available

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

    Varna 726050, 9010
    Bulgaria

    Active - Recruiting

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63
    Czechia

    Site Not Available

  • Krajska nemocnice Liberec a.s.

    Liberec 3071961, 460 63
    Czechia

    Active - Recruiting

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    Mlada Boleslav, 293 50
    Czechia

    Site Not Available

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    Mladá Boleslav 3070544, 293 50
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc 3069011, 779 00
    Czechia

    Active - Recruiting

  • Faculty Hospital Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Faculty Hospital Ostrava

    Ostrava 3068799, 708 52
    Czechia

    Active - Recruiting

  • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

    Prague 3067696, 169 02
    Czechia

    Active - Recruiting

  • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

    Praha 6, 169 02
    Czechia

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, 00290
    Finland

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki 658225, 00290
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere, 33520
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere 634963, 33520
    Finland

    Active - Recruiting

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

    Athens, 115 26
    Greece

    Site Not Available

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

    Athens 264371, 115 26
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklion, 711 10
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion 261745, 711 10
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklon, 711 10
    Greece

    Site Not Available

  • University Hospital of Larissa

    Larisa, 412 21
    Greece

    Site Not Available

  • University Hospital of Larissa

    Larissa 258576, 412 21
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki 734077, 564 29
    Greece

    Active - Recruiting

  • Erzsebet Furdo Gyogyaszati es Szurokozpont

    Miskolc, 3530
    Hungary

    Site Not Available

  • Erzsebet Furdo Gyogyaszati es Szurokozpont

    Miskolc 717582, 3530
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pecs, 7623
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs 3046526, 7623
    Hungary

    Active - Recruiting

  • Szegedi Tudományegyetem ÁOK

    Szeged, 6720
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem ÁOK

    Szeged 715429, 6720
    Hungary

    Active - Recruiting

  • Mater Private Hospital

    Dublin, 7
    Ireland

    Site Not Available

  • Mater Private Hospital

    Dublin 2964574, 7
    Ireland

    Active - Recruiting

  • Institute of Eye Surgery

    Waterford,
    Ireland

    Site Not Available

  • Institute of Eye Surgery

    Waterford 2960992,
    Ireland

    Active - Recruiting

  • Barzilai Medical Center

    Ashkelon, 7827800
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon 295620, 7827800
    Israel

    Active - Recruiting

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100
    Israel

    Active - Recruiting

  • Soroka university medical center

    Beer Sheva, 8489501
    Israel

    Site Not Available

  • Soroka university medical center

    Beersheba 295530, 8489501
    Israel

    Active - Recruiting

  • Carmel medical center

    Haifa 294801, 3436212
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem 281184, 91031
    Israel

    Active - Recruiting

  • Latvian-American Eye Center

    Riga, 1009
    Latvia

    Active - Recruiting

  • Pauls Stradins Clinical University hospital

    Riga, 1002
    Latvia

    Site Not Available

  • Riga East Clinical University hospital Bikernieki

    Riga, 1006
    Latvia

    Active - Recruiting

  • Latvian-American Eye Center

    Riga 456172, 1009
    Latvia

    Active - Recruiting

  • Pauls Stradins Clinical University hospital

    Riga 456172, 1002
    Latvia

    Active - Recruiting

  • Riga East Clinical University hospital Bikernieki

    Riga 456172, 1006
    Latvia

    Active - Recruiting

  • Jeroen Bosch Ziekenhuis

    'S Hertogenbosch, 5223 GZ
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch 2747351, 5223 GZ
    Netherlands

    Active - Recruiting

  • ETZ Elisabeth

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • ETZ Elisabeth

    Tilburg 2746301, 5022 GC
    Netherlands

    Active - Recruiting

  • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

    Bielsk Podlaski, 17-100
    Poland

    Site Not Available

  • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

    Bielsk Podlaski 775986, 17-100
    Poland

    Active - Recruiting

  • Centrum Uslug Medycznych OKO-MED

    Grudziądz 3098218, 86-300
    Poland

    Active - Recruiting

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

    Lodz 3093133, 90-549
    Poland

    Active - Recruiting

  • Szpital Wojewodzki w Poznaniu

    Poznan 3088171, 60-479
    Poland

    Active - Recruiting

  • Pomorski Uniwersytet Medyczny

    Szczecin 3083829, 70-111
    Poland

    Active - Recruiting

  • Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy

    Wejherowo 3082473, 84-200
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

    Zielona Góra 3080165, 65-046
    Poland

    Active - Recruiting

  • Espaco Medico Coimbra

    Coimbra, 3030-163
    Portugal

    Site Not Available

  • Espaco Medico Coimbra

    Coimbra 2740637, 3030-163
    Portugal

    Active - Recruiting

  • Hospital CUF Tejo

    Lisboa, 1350-352
    Portugal

    Active - Recruiting

  • IMO - Instituto de Microcirurgia Ocular

    Lisboa, 1600-209
    Portugal

    Site Not Available

  • Hospital CUF Tejo

    Lisbon 2267057, 1350-352
    Portugal

    Active - Recruiting

  • IMO - Instituto de Microcirurgia Ocular

    Lisbon 2267057, 1600-209
    Portugal

    Active - Recruiting

  • ULS Lisboa Ocidental - Hospital Egas Moniz

    Lisbon 2267057, 1349-019
    Portugal

    Active - Recruiting

  • Hospital de Sao Joao

    Porto, 4200-319
    Portugal

    Site Not Available

  • Hospital de Sao Joao

    Porto 2735943, 4200-319
    Portugal

    Active - Recruiting

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov, 075 01
    Slovakia

    Site Not Available

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov 723358, 075 01
    Slovakia

    Active - Recruiting

  • Fakultna nemocnica Trencin Ocna klinika

    Trencin, 911 71
    Slovakia

    Site Not Available

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín 3057140, 911 71
    Slovakia

    Active - Recruiting

  • Fakultna nemocnica Trnava

    Trnava, 917 75
    Slovakia

    Site Not Available

  • Fakultna nemocnica Trnava

    Trnava 3057124, 917 75
    Slovakia

    Active - Recruiting

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

    Zvolen 3056459, 960 01
    Slovakia

    Active - Recruiting

  • General Hospital Murska Sobota

    Murska Sobota, 9000
    Slovenia

    Site Not Available

  • General Hospital Murska Sobota

    Murska Sobota 3194648, 9000
    Slovenia

    Active - Recruiting

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