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Neovascular Age-related Macular DegenerationNCT06680817

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

An observational study of Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Hoffmann-La Roche at 59 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Faricimab
How many people
875 participants
Where
59 sitesin 15 countries
Study dates
5 Feb 2025to 30 Jun 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

59 sites in 15 countries.

59 sites in 15 countries

Poland7 sites

  • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

    Bielsk Podlaski, 17-100

  • Centrum Uslug Medycznych OKO-MED

    Grudziądz, 86-300

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

    Lodz, 90-549

  • Szpital Wojewodzki w Poznaniu

    Poznan, 60-479

  • Pomorski Uniwersytet Medyczny

    Szczecin, 70-111

  • Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy

    Wejherowo, 84-200

  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

    Zielona Góra, 65-046

Other trials in Poland

Bulgaria6 sites

  • Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology

    Plovdiv, 4000

  • Eye Medical Center St. Luka

    Plovdiv, 4002

  • Eye Diseases Medical Center LUX OPTICS;ophthalmology

    Sofia, 1164

  • Tokuda Hospital

    Sofia, 1407

  • Medical Clinic Svetlina

    Sofia

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

    Varna, 9010

Other trials in Bulgaria

Austria5 sites

  • LKH-Univ.Klinikum Graz

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021

  • Medizinische Universitat Wien

    Vienna, 1090

  • Hanusch Krankenhaus

    Vienna, 1140

Other trials in Austria

Czechia5 sites

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    Mladá Boleslav, 293 50

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Faculty Hospital Ostrava

    Ostrava, 708 52

  • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

    Prague, 169 02

Other trials in Czechia

Israel5 sites

  • Barzilai Medical Center

    Ashkelon, 7827800

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100

  • Soroka university medical center

    Beersheba, 8489501

  • Carmel medical center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 91031

Other trials in Israel

Portugal5 sites

  • Espaco Medico Coimbra

    Coimbra, 3030-163

  • ULS Lisboa Ocidental - Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital CUF Tejo

    Lisbon, 1350-352

  • IMO - Instituto de Microcirurgia Ocular

    Lisbon, 1600-209

  • Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

Greece4 sites

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

    Athens, 115 26

  • University General Hospital of Heraklion

    Heraklion, 711 10

  • University Hospital of Larissa

    Larissa, 412 21

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29

Other trials in Greece

Romania4 sites

  • Retina Clinic

    Bucharest, 14146

  • Clinica Bine

    Bucharest, DUMMY_VALUE

  • Vista Vision

    Bucurescti, DUMMY_VALUE

  • Centrul Oftalmologic Dr. Munteanu

    Timișoara, DUMMY_VALUE

Other trials in Romania

Slovakia4 sites

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov, 075 01

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín, 911 71

  • Fakultna nemocnica Trnava

    Trnava, 917 75

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

    Zvolen, 960 01

Other trials in Slovakia

Hungary3 sites

  • Erzsebet Furdo Gyogyaszati es Szurokozpont

    Miskolc, 3530

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7623

  • Szegedi Tudományegyetem ÁOK

    Szeged, 6720

Other trials in Hungary

Ireland3 sites

  • Mater Private Hospital

    Dublin, 7

  • Bon Secours Hospital, Limerick

    Limerick, V94 HE2T

  • Institute of Eye Surgery

    Waterford

Other trials in Ireland

Latvia3 sites

  • Pauls Stradins Clinical University hospital

    Riga, 1002

  • Riga East Clinical University hospital Bikernieki

    Riga, 1006

  • Latvian-American Eye Center

    Riga, 1009

Other trials in Latvia

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki, 00029

  • Tampere University Hospital

    Tampere, 33520

Other trials in Finland

Netherlands2 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • ETZ Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

Slovenia1 site

  • General Hospital Murska Sobota

    Murska Sobota, 9000

Other trials in Slovenia

About this study

Official title: 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.

Being tested
Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called VABYSMO®, RO6867461, RG7716

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

Study groups in NCT06680817
Study groupRoleWhat they receive
Cohort 1: Faricimab for nAMDThis cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.
Receives: Drug: Faricimab
Cohort 2: Faricimab for DMEThis cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Index Date and 12 months

Secondary outcomes (17)

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

    Measured: Index Date and 3, 6, and 24 months

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

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

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

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

  4. Number of Faricimab Intravitreal Injections per Eye per Year

    Measured: 12 and 24 months

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

    Measured: Approximately 4 months

  6. Total Number of Visits and Number of Visits With or Without Treatment Over Time

    Measured: 3, 6, 12, and 24 months

  7. Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

    Measured: From Index Date to 24 months

  8. 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

    Measured: 3, 6, 12, and 24 months

  9. 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

    Measured: 12 and 24 months

  10. Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

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

  11. Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments

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

  12. Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits

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

  13. Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals

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

  14. 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

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

  15. Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date

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

  16. Number of Participants with at Least One Ocular Adverse Event

    Measured: Approximately 2 years

  17. Number of Participants with at Least One Non-Ocular Adverse Event

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start5 Feb 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
875 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680817
Sponsor's protocol ID
MR45586
Status last verified
Oct 2026
First submitted
6 Nov 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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