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

NCT06680817 | Recruiting

• 1 other identifier: MR45586
• Study Type: observational
• Target: 850
• Locations: 14 countries
• Sites: 58

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity from Index Date to 12 Months

  The index date is defined as the date of the first faricimab treatment injection in the eye.

  Index Date and 12 months

Secondary Outcomes (17)

• Change in Visual Acuity from Index Date to 3, 6, and 24 Months

  Index Date and 3, 6, and 24 months

• Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months

  Index Date and 3, 6, 12, and 24 months

• Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time

  Index Date and 3, 6, 12, and 24 months

• Number of Faricimab Intravitreal Injections per Eye per Year

  12 and 24 months

• Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated

  Approximately 4 months

Study Arms (2)

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.

Drug: Faricimab

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.

Drug: Faricimab

Interventions

Faricimab DRUG

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

Also known as: VABYSMO®, RO6867461, RG7716

Cohort 1: Faricimab for nAMD; Cohort 2: Faricimab for DME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (59)

LKH-Univ.Klinikum Graz

Graz, 8036, Austria

RECRUITING

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Kepler Universitätskliniken GmbH - Med Campus III

Linz, 4021, Austria

RECRUITING

Medizinische Universitat Wien

Vienna, 1090, Austria

RECRUITING

Hanusch Krankenhaus

Vienna, 1140, Austria

RECRUITING

Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

Plovdiv, 4000, Bulgaria

RECRUITING

Eye Medical Center St. Luka

Plovdiv, 4002, Bulgaria

RECRUITING

Eye Diseases Medical Center LUX OPTICS;ophthalmology

Sofia, 1164, Bulgaria

RECRUITING

Tokuda Hospital

Sofia, 1407, Bulgaria

RECRUITING

Medical Clinic Svetlina

Sofia, Bulgaria

RECRUITING

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

Varna, 9010, Bulgaria

RECRUITING

Krajska nemocnice Liberec a.s.

Liberec, 460 63, Czechia

RECRUITING

Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

Mladá Boleslav, 293 50, Czechia

RECRUITING

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

RECRUITING

Faculty Hospital Ostrava

Ostrava, 708 52, Czechia

RECRUITING

Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

Prague, 169 02, Czechia

RECRUITING

Helsinki University Central Hospital

Helsinki, 00290, Finland

RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

RECRUITING

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

Athens, 115 26, Greece

RECRUITING

University General Hospital of Heraklion

Heraklion, 711 10, Greece

RECRUITING

University Hospital of Larissa

Larissa, 412 21, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 564 29, Greece

RECRUITING

Erzsebet Furdo Gyogyaszati es Szurokozpont

Miskolc, 3530, Hungary

RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7623, Hungary

RECRUITING

Szegedi Tudományegyetem ÁOK

Szeged, 6720, Hungary

RECRUITING

Mater Private Hospital

Dublin, 7, Ireland

RECRUITING

Bon Secours Hospital, Limerick

Limerick, V94 HE2T, Ireland

RECRUITING

Institute of Eye Surgery

Waterford, Ireland

RECRUITING

Barzilai Medical Center

Ashkelon, 7827800, Israel

RECRUITING

Shamir Medical Center Assaf Harofeh

Beer Jacob, 0073100, Israel

RECRUITING

Soroka university medical center

Beersheba, 8489501, Israel

RECRUITING

Carmel medical center

Haifa, 3436212, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

Pauls Stradins Clinical University hospital

Riga, 1002, Latvia

RECRUITING

Riga East Clinical University hospital Bikernieki

Riga, 1006, Latvia

RECRUITING

Latvian-American Eye Center

Riga, 1009, Latvia

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

RECRUITING

ETZ Elisabeth

Tilburg, 5022 GC, Netherlands

RECRUITING

NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

Bielsk Podlaski, 17-100, Poland

RECRUITING

Centrum Uslug Medycznych OKO-MED

Grudziądz, 86-300, Poland

RECRUITING

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

Lodz, 90-549, Poland

RECRUITING

Szpital Wojewodzki w Poznaniu

Poznan, 60-479, Poland

RECRUITING

Pomorski Uniwersytet Medyczny

Szczecin, 70-111, Poland

RECRUITING

Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy

Wejherowo, 84-200, Poland

RECRUITING

Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

Zielona Góra, 65-046, Poland

RECRUITING

Espaco Medico Coimbra

Coimbra, 3030-163, Portugal

RECRUITING

ULS Lisboa Ocidental - Hospital Egas Moniz

Lisbon, 1349-019, Portugal

RECRUITING

Hospital CUF Tejo

Lisbon, 1350-352, Portugal

RECRUITING

IMO - Instituto de Microcirurgia Ocular

Lisbon, 1600-209, Portugal

RECRUITING

Hospital de Sao Joao

Porto, 4200-319, Portugal

RECRUITING

Retina Clinic

Bucharest, 14146, Romania

RECRUITING

Clinica Bine

Bucharest, Romania

RECRUITING

Vista Vision

Bucurescti, Romania

RECRUITING

Centrul Oftalmologic Dr. Munteanu

Timișoara, Romania

RECRUITING

Nemocnica s poliklinikou Trebišov, a.s.

Trebišov, 075 01, Slovakia

RECRUITING

Fakultna nemocnica Trencin Ocna klinika

Trenčín, 911 71, Slovakia

RECRUITING

Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia

RECRUITING

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

Zvolen, 960 01, Slovakia

RECRUITING

General Hospital Murska Sobota

Murska Sobota, 9000, Slovenia

RECRUITING

MeSH Terms

Interventions

faricimab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

LA (3); HU (3); CZ (5); RO (4); BU (6); SL (4); PL (7); PT (5); NL (2); FI (2); GR (4); IE (3); AU (5); IL (5)