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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab | Drug | Faricimab will be administered as per local clinical practice and local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Index Date and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity from Index Date to 3, 6, and 24 Months | Index Date and 3, 6, and 24 months | |
| Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months | Index Date and 3, 6, 12, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being treated with faricimab approved for nAMD and DME in real-world, routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Univ.Klinikum Graz | Graz | 8036 | Austria | |||
| Medizinische Universität Innsbruck |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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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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|
| Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time | Index Date and 3, 6, 12, and 24 months |
| Number of Faricimab Intravitreal Injections per Eye per Year | 12 and 24 months |
| Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated | Approximately 4 months |
| Total Number of Visits and Number of Visits With or Without Treatment Over Time | 3, 6, 12, and 24 months |
| Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) | From Index Date to 24 months |
| 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 | 3, 6, 12, and 24 months |
| 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 | 12 and 24 months |
| Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) | Index Date and 3, 6, 12, and 24 months |
| Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments | Index Date and 3, 6, 12, and 24 months |
| Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits | Index Date and 3, 6, 12, and 24 months |
| Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals | Index Date and 3, 6, 12, and 24 months |
| 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 | Index Date and 3, 6, 12, and 24 months |
| Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date | Index Date and 3, 6, 12, and 24 months |
| Number of Participants with at Least One Ocular Adverse Event | Approximately 2 years |
| Number of Participants with at Least One Non-Ocular Adverse Event | Approximately 2 years |
| Innsbruck |
| 6020 |
| Austria |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | 4021 | Austria |
| Medizinische Universitat Wien | Vienna | 1090 | Austria |
| Hanusch Krankenhaus | Vienna | 1140 | Austria |
| Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology | Plovdiv | 4000 | Bulgaria |
| Eye Medical Center St. Luka | Plovdiv | 4002 | Bulgaria |
| Eye Diseases Medical Center LUX OPTICS;ophthalmology | Sofia | 1164 | Bulgaria |
| Tokuda Hospital | Sofia | 1407 | Bulgaria |
| Medical Clinic Svetlina | Sofia | Bulgaria |
| Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology | Varna | 9010 | Bulgaria |
| Krajska nemocnice Liberec a.s. | Liberec | 460 63 | Czechia |
| Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt | Mladá Boleslav | 293 50 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Faculty Hospital Ostrava | Ostrava | 708 52 | Czechia |
| Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha | Prague | 169 02 | Czechia |
| Helsinki University Central Hospital | Helsinki | 00290 | Finland |
| Tampere University Hospital | Tampere | 33520 | Finland |
| General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross | Athens | 115 26 | Greece |
| University General Hospital of Heraklion | Heraklion | 711 10 | Greece |
| University Hospital of Larissa | Larissa | 412 21 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 564 29 | Greece |
| Erzsebet Furdo Gyogyaszati es Szurokozpont | Miskolc | 3530 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | 7623 | Hungary |
| Szegedi Tudományegyetem ÁOK | Szeged | 6720 | Hungary |
| Mater Private Hospital | Dublin | 7 | Ireland |
| Bon Secours Hospital, Limerick | Limerick | V94 HE2T | Ireland |
| Institute of Eye Surgery | Waterford | Ireland |
| Barzilai Medical Center | Ashkelon | 7827800 | Israel |
| Shamir Medical Center Assaf Harofeh | Beer Jacob | 0073100 | Israel |
| Soroka university medical center | Beersheba | 8489501 | Israel |
| Carmel medical center | Haifa | 3436212 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Pauls Stradins Clinical University hospital | Riga | 1002 | Latvia |
| Riga East Clinical University hospital Bikernieki | Riga | 1006 | Latvia |
| Latvian-American Eye Center | Riga | 1009 | Latvia |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| ETZ Elisabeth | Tilburg | 5022 GC | Netherlands |
| NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa | Bielsk Podlaski | 17-100 | Poland |
| Centrum Uslug Medycznych OKO-MED | Grudziądz | 86-300 | Poland |
| USK Nr 2 im. WAM w Lodzi, Centralny Szpital Weteranow | Lodz | 90-549 | Poland |
| Szpital Wojewodzki w Poznaniu | Poznan | 60-479 | Poland |
| Pomorski Uniwersytet Medyczny | Szczecin | 70-111 | Poland |
| Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy | Wejherowo | 84-200 | Poland |
| Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze | Zielona Góra | 65-046 | Poland |
| Espaco Medico Coimbra | Coimbra | 3030-163 | Portugal |
| ULS Lisboa Ocidental - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Hospital CUF Tejo | Lisbon | 1350-352 | Portugal |
| IMO - Instituto de Microcirurgia Ocular | Lisbon | 1600-209 | Portugal |
| Hospital de Sao Joao | Porto | 4200-319 | Portugal |
| Retina Clinic | Bucharest | 14146 | Romania |
| Clinica Bine | Bucharest | Romania |
| Vista Vision | Bucurescti | Romania |
| Centrul Oftalmologic Dr. Munteanu | Timișoara | Romania |
| Nemocnica s poliklinikou Trebišov, a.s. | Trebišov | 075 01 | Slovakia |
| Fakultna nemocnica Trencin Ocna klinika | Trenčín | 911 71 | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 917 75 | Slovakia |
| OFTAL s.r.o. Specializovana nemocnica v odbore oftalmologia Zvolen | Zvolen | 960 01 | Slovakia |
| General Hospital Murska Sobota | Murska Sobota | 9000 | Slovenia |
| ID | Term |
|---|---|
| C000723200 | faricimab |
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