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

Last updated: March 21, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Diabetic Macular Edema

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, as defined by local regulations and local faricimab product label, who areinitiating treatment with faricimab at time of enrollment or have initiatedtreatment with faricimab within 3 months prior to patient enrollment, in diabeticmacular edema (DME) or neovascular age-related macular degeneration (nAMD) in atleast one eye according to the investigator's discretion in routine clinicalpractice for anti-VEGF treatment naïve and pre-treated patients.

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

Exclusion

Exclusion Criteria:

  • Concomitant participation of the patient in any investigational ophthalmologyclinical trial that includes receipt of any ophthalmological investigational drug orprocedure within the last 28 days prior to enrollment

  • Current participation in any interventional clinical study

  • Active ocular inflammation and/or suspected/active ocular infection in either eye

  • Patients in whom the study eye has been treated with faricimab for more than 3months prior to enrollment

  • 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 15, 2028

Connect with a study center

  • LKH-Univ.Klinikum Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021
    Austria

    Active - Recruiting

  • Hanusch Krankenhaus

    Wien, 1140
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • Eye Medical Center St. Luka

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Medical Clinic Svetlina

    Sofia,
    Bulgaria

    Active - Recruiting

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    Mlada Boleslav, 293 50
    Czechia

    Active - Recruiting

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

    Athens, 115 26
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklion, 711 10
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklon, 711 10
    Greece

    Active - Recruiting

  • University Hospital of Larissa

    Larisa, 412 21
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29
    Greece

    Active - Recruiting

  • Erzsebet Furdo Gyogyaszati es Szurokozpont

    Miskolc, 3530
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pecs, 7623
    Hungary

    Active - Recruiting

  • Institute of Eye Surgery

    Waterford,
    Ireland

    Active - Recruiting

  • Latvian-American Eye Center

    Riga, 1009
    Latvia

    Active - Recruiting

  • Pauls Stradins Clinical University hospital

    Riga, 1002
    Latvia

    Active - Recruiting

  • Riga East Clinical University hospital Bikernieki

    Riga, 1006
    Latvia

    Active - Recruiting

  • Jeroen Bosch Ziekenhuis

    'S Hertogenbosch, 5223 GZ
    Netherlands

    Active - Recruiting

  • ETZ Elisabeth

    Tilburg, 5022 GC
    Netherlands

    Active - Recruiting

  • Hospital de Sao Joao

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov, 075 01
    Slovakia

    Active - Recruiting

  • Fakultna nemocnica Trencin Ocna klinika

    Trencin, 911 71
    Slovakia

    Active - Recruiting

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