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

Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Faricimab

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: MR45586 https://forpatients.roche.com/ No attachments to email below.; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • LKH-Univ.Klinikum Graz
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universität Innsbruck
  • Linz, Austria, 4021
    • Recruiting
    • Kepler Universitätskliniken GmbH - Med Campus III
  • Vienna, Austria, 1090
    • Recruiting
    • Medizinische Universität Wien
  • Vienna, Austria, 1140
    • Recruiting
    • Hanusch Krankenhaus
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • Eye Medical Center St. Luka
  • Sofia, Bulgaria
    • Recruiting
    • Medical Clinic Svetlina
  • Sofia, Bulgaria, 1407
    • Recruiting
    • Tokuda Hospital
  • Sofia, Bulgaria, 1164
    • Recruiting
    • Eye Diseases Medical Center LUX OPTICS;ophthalmology
  • Varna, Bulgaria, 9010
    • Recruiting
    • Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology
• Czechia
  • Liberec, Czechia, 460 63
    • Recruiting
    • Krajska nemocnice Liberec a.s.
  • Mladá Boleslav, Czechia, 293 50
    • Recruiting
    • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 708 52
    • Recruiting
    • Faculty Hospital Ostrava
  • Prague, Czechia, 169 02
    • Recruiting
    • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Helsinki University Central Hospital
  • Tampere, Finland, 33520
    • Recruiting
    • Tampere University Hospital
• Greece
  • Athens, Greece, 115 26
    • Recruiting
    • General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross
  • Heraklion, Greece, 711 10
    • Recruiting
    • University General Hospital of Heraklion
  • Larissa, Greece, 412 21
    • Recruiting
    • University Hospital of Larissa
  • Thessaloniki, Greece, 564 29
    • Recruiting
    • Papageorgiou General Hospital of Thessaloniki
• Hungary
  • Miskolc, Hungary, 3530
    • Recruiting
    • Erzsebet Furdo Gyogyaszati es Szurokozpont
  • Pécs, Hungary, 7623
    • Recruiting
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6720
    • Recruiting
    • Szegedi Tudományegyetem ÁOK
• Ireland
  • Dublin, Ireland, 7
    • Recruiting
    • Mater Private Hospital
  • Limerick, Ireland, V94 HE2T
    • Recruiting
    • Bon Secours Hospital, Limerick
  • Waterford, Ireland
    • Recruiting
    • Institute of Eye Surgery
• Israel
  • Ashkelon, Israel, 7827800
    • Recruiting
    • Barzilai Medical Center
  • Beer Jacob, Israel, 0073100
    • Recruiting
    • Shamir Medical Center Assaf Harofeh
  • Beersheba, Israel, 8489501
    • Recruiting
    • Soroka university medical center
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
  • Jerusalem, Israel, 91031
    • Recruiting
    • Shaare Zedek Medical Center
• Latvia
  • Riga, Latvia, 1002
    • Recruiting
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1006
    • Recruiting
    • Riga East Clinical University hospital Bikernieki
  • Riga, Latvia, 1009
    • Recruiting
    • Latvian-American Eye Center
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Recruiting
    • Jeroen Bosch Ziekenhuis
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • ETZ Elisabeth
• Poland
  • Bielsk Podlaski, Poland, 17-100
    • Recruiting
    • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa
  • Grudziądz, Poland, 86-300
    • Recruiting
    • Centrum Uslug Medycznych OKO-MED
  • Lodz, Poland, 90-549
    • Recruiting
    • USK Nr 2 im. WAM w Lodzi, Centralny Szpital Weteranow
  • Poznan, Poland, 60-479
    • Recruiting
    • Szpital Wojewodzki w Poznaniu
  • Szczecin, Poland, 70-111
    • Recruiting
    • Pomorski Uniwersytet Medyczny
  • Wejherowo, Poland, 84-200
    • Recruiting
    • Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy
  • Zielona Góra, Poland, 65-046
    • Recruiting
    • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze
• Portugal
  • Coimbra, Portugal, 3030-163
    • Recruiting
    • Espaco Medico Coimbra
  • Lisbon, Portugal, 1350-352
    • Recruiting
    • Hospital Cuf Tejo
  • Lisbon, Portugal, 1600-209
    • Recruiting
    • IMO - Instituto de Microcirurgia Ocular
  • Lisbon, Portugal, 1349-019
    • Recruiting
    • ULS Lisboa Ocidental - Hospital Egas Moniz
  • Porto, Portugal, 4200-319
    • Recruiting
    • Hospital de Sao Joao
• Romania
  • Bucharest, Romania, 14146
    • Recruiting
    • Retina Clinic
  • Bucharest, Romania
    • Recruiting
    • Clinica Bine
  • Bucurescti, Romania
    • Recruiting
    • Vista Vision
  • Timișoara, Romania
    • Recruiting
    • Centrul Oftalmologic Dr. Munteanu
• Slovakia
  • Trebišov, Slovakia, 075 01
    • Recruiting
    • Nemocnica s poliklinikou Trebišov, a.s.
  • Trenčín, Slovakia, 911 71
    • Recruiting
    • Fakultna nemocnica Trencin Ocna klinika
  • Trnava, Slovakia, 917 75
    • Recruiting
    • Fakultna nemocnica Trnava
  • Zvolen, Slovakia, 960 01
    • Recruiting
    • OFTAL s.r.o. Specializovana nemocnica v odbore oftalmologia Zvolen
• Slovenia
  • Murska Sobota, Slovenia, 9000
    • Recruiting
    • General Hospital Murska Sobota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Faricimab will be administered as per local clinical practice and local labeling.; Other Names: RO6867461; RG7716; VABYSMO®
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; Faricimab will be administered as per local clinical practice and local labeling.; Other Names: RO6867461; RG7716; VABYSMO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change in Visual Acuity from Index Date to 3, 6, and 24 Months	Index Date and 3, 6, 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
Total Number of Visits and Number of Visits With or Without Treatment Over Time	3, 6, 12, and 24 months
Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)	From Index Date to 24 months
Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)	Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments	Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits	Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals	Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date	Index Date and 3, 6, 12, and 24 months
Number of Participants with at Least One Ocular Adverse Event	Approximately 2 years
Number of Participants with at Least One Non-Ocular Adverse Event	Approximately 2 years
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
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
Percentage of Eyes With Treatment Switch from Faricimab by Reason for Switch in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated	3, 6, 12, and 24 months
Percentage of Eyes Obtaining Treatment Intervals of Once Every 8, 12, or 16 Weeks or Other Intervals in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated	12 and 24 months
Change in Visual Acuity from Index Date Over Time, According to Type of anti-VEGF Pre-Treatment and Number of Previous Injections for Preceding Regimen at Index Date	Index Date and 3, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Macular Edema; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; faricimab
• Other Study ID Numbers: MR45586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No