Clinical trial NCT06680817: A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Official title: Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated with faricimab approved for nAMD and DME in real-world, routine clinical practice.

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.


Eligibility criteria: Inclusion Criteria:

* Patients, as defined by local regulations and local faricimab product label, who are initiating treatment with faricimab at time of enrollment or have initiated treatment with faricimab within 3 months prior to patient enrollment, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye according to the investigator's discretion in routine clinical practice for anti-VEGF treatment naïve and pre-treated patients.
* Patients have received at least one faricimab treatment (the first dose) in the study eye.

Exclusion Criteria:

* Concomitant participation of the patient in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure 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 3 months prior to enrollment
* 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)

Primary outcomes:
measure: Change in Visual Acuity from Index Date to 12 Months
timeFrame: Index Date and 12 months
Secondary outcomes:
measure: Change in Visual Acuity from Index Date to 3, 6, and 24 Months
timeFrame: Index Date and 3, 6, and 24 months
measure: Change in Central Subfield Thickness (CST) from Index Date to 3, 6, and 24 Months
timeFrame: Index Date and 3, 6, and 24 months
measure: Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Number of Faricimab Intravitreal Injections per Eye per Year
timeFrame: 12 and 24 months
measure: Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are Treatment Naive or anti-VEGF pre-Treated
timeFrame: Approximately 4 months
measure: Total Number of Visits and Number of Visits With or Without Treatment Over Time
timeFrame: 3, 6, 12, and 24 months
measure: Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)
timeFrame: From Index Date to 24 months
measure: Percentage of Eyes With Treatment Switch from Faricimab by Reason for Switch in Participants who are Treatment Naive or anti-VEGF pre-Treated
timeFrame: 3, 6, 12, and 24 months
measure: Percentage of Eyes Obtaining Treatment Intervals of Once Every 8, 12, or 16 Weeks or Other Intervals in Participants who are Treatment Naive or anti-VEGF pre-Treated
timeFrame: 12 and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Type of Pre-Treatment and Number of Previous Injections for Preceding Regimen at Index Date
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date
timeFrame: Index Date and 3, 6, 12, and 24 months
measure: Number of Participants with at Least One Ocular Adverse Event
timeFrame: Approximately 2 years
measure: Number of Participants with at Least One Non-Ocular Adverse Event
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Hanusch Krankenhaus
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology
city: Plovdiv
country: Bulgaria
facility: Eye Medical Center St. Luka
city: Sofia
country: Bulgaria
facility: Medical Clinic Svetlina
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec a.s.
city: Mlada Boleslav
country: Czechia
facility: Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Faculty Hospital Ostrava
city: Praha 6
country: Czechia
facility: Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Athens
country: Greece
facility: General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross
city: Heraklon
country: Greece
facility: University General Hospital of Heraklion
city: Larisa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Miskolc
country: Hungary
facility: Erzsebet Furdo Gyogyaszati es Szurokozpont
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK
city: Waterford
country: Ireland
facility: Institute of Eye Surgery
city: Beer Sheva
country: Israel
facility: Soroka university medical center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University hospital
city: Riga
country: Latvia
facility: Riga East Clinical University hospital Bikernieki
city: Riga
country: Latvia
facility: Latvian-American Eye Center
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Bielsk Podlaski
country: Poland
facility: NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa
city: Lisboa
country: Portugal
facility: Hospital CUF Tejo
city: Lisboa
country: Portugal
facility: IMO - Instituto de Microcirurgia Ocular
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Trebišov
country: Slovakia
facility: Nemocnica s poliklinikou Trebišov, a.s.
city: Trencin
country: Slovakia
facility: Fakultna nemocnica Trencin Ocna klinika
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Murska Sobota
country: Slovenia
facility: General Hospital Murska Sobota
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: