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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Austria
LKH-Univ.Klinikum Graz
RECRUITING
Graz
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Kepler Universitätskliniken GmbH - Med Campus III
RECRUITING
Linz
Hanusch Krankenhaus
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Bulgaria
Eye Medical Center St. Luka
RECRUITING
Plovdiv
Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology
RECRUITING
Plovdiv
Eye Diseases Medical Center LUX OPTICS;ophthalmology
RECRUITING
Sofia
Medical Clinic Svetlina
RECRUITING
Sofia
Tokuda Hospital
RECRUITING
Sofia
Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology
RECRUITING
Varna
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Tampere University Hospital
RECRUITING
Tampere
Greece
General Hospital of Athens Korgialeneio - Benakeio Hellenic Red Cross
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklon
University Hospital of Larissa
RECRUITING
Larissa
Papageorgiou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Erzsebet Furdo Gyogyaszati es Szurokozpont
RECRUITING
Miskolc
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
Szegedi Tudományegyetem ÁOK
RECRUITING
Szeged
Ireland
Mater Private Hospital
RECRUITING
Dublin
Institute of Eye Surgery
RECRUITING
Waterford
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Soroka university medical center
RECRUITING
Beersheba
Carmel medical center
RECRUITING
Haifa
Latvia
Latvian-American Eye Center
RECRUITING
Riga
Pauls Stradins Clinical University hospital
RECRUITING
Riga
Riga East Clinical University hospital Bikernieki
RECRUITING
Riga
Netherlands
Jeroen Bosch Ziekenhuis
RECRUITING
's-hertogenbosch
ETZ Elisabeth
RECRUITING
Tilburg
Poland
NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa
RECRUITING
Bielsk Podlaski
Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy
RECRUITING
Wejherowo
Portugal
Espaco Medico Coimbra
RECRUITING
Coimbra
Hospital CUF Tejo
RECRUITING
Lisbon
IMO - Instituto de Microcirurgia Ocular
RECRUITING
Lisbon
Hospital de Sao Joao
RECRUITING
Porto
Slovakia
Nemocnica s poliklinikou Trebišov, a.s.
RECRUITING
Trebišov
Fakultna nemocnica Trencin Ocna klinika
RECRUITING
Trenčín
Fakultna nemocnica Trnava
RECRUITING
Trnava
Slovenia
General Hospital Murska Sobota
RECRUITING
Murska Sobota
Contact Information
Primary
Reference Study ID Number: MR45586 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 850
Treatments
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.
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.
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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