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Clinical Trials in Ireland / NCT06680817
Active, not recruiting Observational

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

NCT06680817 · tracked via the Priya Life Science Ireland tracker
Sponsor
Hoffmann-La Roche
Phase
Observational
Started
2025-02-05
Last updated
2026-07-07

Condition(s) studied

Neovascular Age-related Macular DegenerationDiabetic Macular Edema

Investigational drug(s) / intervention(s)

Faricimab

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
LKH-Univ.Klinikum Graz Graz Austria
Medizinische Universität Innsbruck Innsbruck Austria
Kepler Universitätskliniken GmbH - Med Campus III Linz Austria
Medizinische Universitat Wien Vienna Austria
Hanusch Krankenhaus Vienna Austria
Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology Plovdiv Bulgaria
Eye Medical Center St. Luka Plovdiv Bulgaria
Eye Diseases Medical Center LUX OPTICS;ophthalmology Sofia Bulgaria
Tokuda Hospital Sofia Bulgaria
Medical Clinic Svetlina Sofia Bulgaria
Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology Varna Bulgaria
Krajska nemocnice Liberec a.s. Liberec Czechia
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt Mladá Boleslav Czechia
Fakultni nemocnice Olomouc Olomouc Czechia
Faculty Hospital Ostrava Ostrava Czechia
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha Prague Czechia
Helsinki University Central Hospital Helsinki Finland
Tampere University Hospital Tampere Finland
General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross Athens Greece
University General Hospital of Heraklion Heraklion Greece
University Hospital of Larissa Larissa Greece
Papageorgiou General Hospital of Thessaloniki Thessaloniki Greece
Erzsebet Furdo Gyogyaszati es Szurokozpont Miskolc Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Pécs Hungary
Szegedi Tudományegyetem ÁOK Szeged Hungary
Mater Private Hospital Dublin Ireland
Bon Secours Hospital, Limerick Limerick Ireland
Institute of Eye Surgery Waterford Ireland
Barzilai Medical Center Ashkelon Israel
Shamir Medical Center Assaf Harofeh Beer Jacob Israel
Soroka university medical center Beersheba Israel
Carmel medical center Haifa Israel
Shaare Zedek Medical Center Jerusalem Israel
Pauls Stradins Clinical University hospital Riga Latvia
Riga East Clinical University hospital Bikernieki Riga Latvia
Latvian-American Eye Center Riga Latvia
Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
ETZ Elisabeth Tilburg Netherlands
NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa Bielsk Podlaski Poland
Centrum Uslug Medycznych OKO-MED Grudziądz Poland

+ 19 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680817 on ClinicalTrials.gov ↗ ← All trials in Ireland