Actively Recruiting
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema
Led by Hoffmann-La Roche · Updated on 2026-05-11
850
Participants Needed
59
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. This observational study aims to evaluate the effectiveness, safety, treatment patterns, and health economics of faricimab in real-world clinical practice over a two-year follow-up period. The study includes patients both new to anti-VEGF treatment and those who have been previously treated with anti-VEGF therapies. Participants will receive faricimab as guided by local clinical practice and labeling. The study divides participants into two sub-cohorts based on their prior eye treatment history: those naive to anti-VEGF treatment and those previously treated. The study is designed to observe treatment regimens, dosing, and clinical outcomes in routine care settings without experimental interventions. During the study, participants will be monitored for changes in visual acuity and central subfield thickness at multiple time points up to 24 months. Researchers will collect data on injection frequency, treatment intervals, and any switch in treatment. Safety will be assessed by tracking ocular and non-ocular adverse events. The study emphasizes the collection of real-world clinical and economic data, following each patient for up to two years.
CONDITIONS
Brief Title
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving faricimab according to local product labeling who started treatment at or within 3 months before consent
- Patients with diabetic macular edema or neovascular age-related macular degeneration in at least one eye
- Patients who have received at least one faricimab injection in the affected eye
- Patients with available visual acuity and central subfield thickness data at baseline or within 4 months prior
You will not qualify if you...
- Participation in any investigational ophthalmology trial with investigational drugs or procedures within 28 days before consent
- Concurrent participation in any interventional clinical study
- Active eye inflammation or suspected/active eye infection in either eye
- Participation in patient support programs such as market research, post-trial access, or compassionate use programs
- Presence of non-ocular sight-threatening diseases affecting the primary study endpoint
- Known hypersensitivity to faricimab or any of its components as per product label
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive Faricimab as per local clinical practice and labeling for neovascular age-related macular degeneration or diabetic macular edema.
Visits and injections occur according to routine clinical care over 24 months
Duration - Up to 24 months
Participants are monitored for visual acuity, central subfield thickness, treatment regimens, and adverse events during and after treatment.
Follow-up visits at approximately 3, 6, 12, and 24 months
Trial Site Locations
Total: 59 locations
1
LKH-Univ.Klinikum Graz
Graz, Austria, 8036
Actively Recruiting
2
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
3
Kepler Universitätskliniken GmbH - Med Campus III
Linz, Austria, 4021
Actively Recruiting
4
Medizinische Universitat Wien
Vienna, Austria, 1090
Actively Recruiting
5
Hanusch Krankenhaus
Vienna, Austria, 1140
Actively Recruiting
6
Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology
Plovdiv, Bulgaria, 4000
Actively Recruiting
7
Eye Medical Center St. Luka
Plovdiv, Bulgaria, 4002
Actively Recruiting
8
Eye Diseases Medical Center LUX OPTICS;ophthalmology
Sofia, Bulgaria, 1164
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9
Tokuda Hospital
Sofia, Bulgaria, 1407
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10
Medical Clinic Svetlina
Sofia, Bulgaria
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11
Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology
Varna, Bulgaria, 9010
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12
Krajska nemocnice Liberec a.s.
Liberec, Czechia, 460 63
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13
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, Czechia, 293 50
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14
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
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15
Faculty Hospital Ostrava
Ostrava, Czechia, 708 52
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16
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Czechia, 169 02
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17
Helsinki University Central Hospital
Helsinki, Finland, 00290
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18
Tampere University Hospital
Tampere, Finland, 33520
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19
General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross
Athens, Greece, 115 26
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20
University General Hospital of Heraklion
Heraklion, Greece, 711 10
Actively Recruiting
21
University Hospital of Larissa
Larissa, Greece, 412 21
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22
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Actively Recruiting
23
Erzsebet Furdo Gyogyaszati es Szurokozpont
Miskolc, Hungary, 3530
Actively Recruiting
24
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary, 7623
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25
Szegedi Tudományegyetem ÁOK
Szeged, Hungary, 6720
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26
Mater Private Hospital
Dublin, Ireland, 7
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27
Bon Secours Hospital, Limerick
Limerick, Ireland, V94 HE2T
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28
Institute of Eye Surgery
Waterford, Ireland
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29
Barzilai Medical Center
Ashkelon, Israel, 7827800
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30
Shamir Medical Center Assaf Harofeh
Beer Jacob, Israel, 0073100
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31
Soroka university medical center
Beersheba, Israel, 8489501
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32
Carmel medical center
Haifa, Israel, 3436212
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33
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Actively Recruiting
34
Pauls Stradins Clinical University hospital
Riga, Latvia, 1002
Actively Recruiting
35
Riga East Clinical University hospital Bikernieki
Riga, Latvia, 1006
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36
Latvian-American Eye Center
Riga, Latvia, 1009
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37
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
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38
ETZ Elisabeth
Tilburg, Netherlands, 5022 GC
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39
NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa
Bielsk Podlaski, Poland, 17-100
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40
Centrum Uslug Medycznych OKO-MED
Grudziądz, Poland, 86-300
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41
USK Nr 2 im. WAM w Lodzi, Centralny Szpital Weteranow
Lodz, Poland, 90-549
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42
Szpital Wojewodzki w Poznaniu
Poznan, Poland, 60-479
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43
Pomorski Uniwersytet Medyczny
Szczecin, Poland, 70-111
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44
Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy
Wejherowo, Poland, 84-200
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45
Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze
Zielona Góra, Poland, 65-046
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46
Espaco Medico Coimbra
Coimbra, Portugal, 3030-163
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47
ULS Lisboa Ocidental - Hospital Egas Moniz
Lisbon, Portugal, 1349-019
Actively Recruiting
48
Hospital CUF Tejo
Lisbon, Portugal, 1350-352
Actively Recruiting
49
IMO - Instituto de Microcirurgia Ocular
Lisbon, Portugal, 1600-209
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50
Hospital de Sao Joao
Porto, Portugal, 4200-319
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51
Retina Clinic
Bucharest, Romania, 14146
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52
Clinica Bine
Bucharest, Romania
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53
Vista Vision
Bucurescti, Romania
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54
Centrul Oftalmologic Dr. Munteanu
Timișoara, Romania
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55
Nemocnica s poliklinikou Trebišov, a.s.
Trebišov, Slovakia, 075 01
Actively Recruiting
56
Fakultna nemocnica Trencin Ocna klinika
Trenčín, Slovakia, 911 71
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57
Fakultna nemocnica Trnava
Trnava, Slovakia, 917 75
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58
OFTAL s.r.o. Specializovana nemocnica v odbore oftalmologia Zvolen
Zvolen, Slovakia, 960 01
Actively Recruiting
59
General Hospital Murska Sobota
Murska Sobota, Slovenia, 9000
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Research Team
R
Reference Study ID Number: MR45586 https://forpatients.roche.com/
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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