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

July 6, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity from Index Date to 12 Months
Time Frame: Index Date and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Visual Acuity from Index Date to 3, 6, and 24 Months
Time Frame: Index Date and 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
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months
Number of Faricimab Intravitreal Injections per Eye per Year
Time Frame: 12 and 24 months
12 and 24 months
Total Number of Visits and Number of Visits With or Without Treatment Over Time
Time Frame: 3, 6, 12, and 24 months
3, 6, 12, and 24 months
Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)
Time Frame: From Index Date to 24 months
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)
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals
Time Frame: Index Date and 3, 6, 12, and 24 months
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
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months
Number of Participants with at Least One Ocular Adverse Event
Time Frame: Approximately 2 years
Approximately 2 years
Number of Participants with at Least One Non-Ocular Adverse Event
Time Frame: Approximately 2 years
Approximately 2 years
Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months
Time Frame: Index Date and 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
Time Frame: Approximately 4 months
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
Time Frame: 3, 6, 12, and 24 months
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
Time Frame: 12 and 24 months
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
Time Frame: Index Date and 3, 6, 12, and 24 months
Index Date and 3, 6, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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