Evaluating the use of faricimab in treating eye conditions
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)
This study is testing how well faricimab works and how safe it is for people with certain eye conditions like age-related macular degeneration or diabetic macular edema who are just starting this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | faricimab |
| Locations | 59 sites (Graz and 58 other locations) |
| Trial ID | NCT06680817 on ClinicalTrials.gov |
What this trial studies
The FaReal study aims to gather real-world clinical insights on the effectiveness and safety of faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). This observational study will follow patients over a two-year period to assess treatment patterns and health economic aspects related to faricimab compared to previous anti-VEGF treatments. Patients who are initiating or have recently started treatment with faricimab will be included in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with nAMD or DME who are starting treatment with faricimab or have begun treatment within the last three months.
Not a fit: Patients currently participating in other investigational ophthalmology trials or those with active ocular infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of faricimab, potentially improving treatment strategies for patients with nAMD and DME.
How similar studies have performed: Other studies evaluating real-world effectiveness of anti-VEGF treatments have shown promising results, suggesting that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Graz and 58 other locations
- LKH-Univ.Klinikum Graz — Graz, Austria (Recruiting)
- Medizinische Universität Innsbruck — Innsbruck, Austria (Recruiting)
- Kepler Universitätskliniken GmbH - Med Campus III — Linz, Austria (Recruiting)
- Medizinische Universitat Wien — Vienna, Austria (Recruiting)
- Hanusch Krankenhaus — Vienna, Austria (Recruiting)
- Multiprofile Hospital for Active Treatment Trimontium OOD Plovdiv;Ophthalmology — Plovdiv, Bulgaria (Recruiting)
- Eye Medical Center St. Luka — Plovdiv, Bulgaria (Recruiting)
- Eye Diseases Medical Center LUX OPTICS;ophthalmology — Sofia, Bulgaria (Recruiting)
- Tokuda Hospital — Sofia, Bulgaria (Recruiting)
- Medical Clinic Svetlina — Sofia, Bulgaria (Recruiting)
- Ambulatory for Group Practice for Specialized Medical Care in Ophthalmology - Dr. Grupchevi OOD;Ophthalmology — Varna, Bulgaria (Recruiting)
- Krajska nemocnice Liberec a.s. — Liberec, Czechia (Recruiting)
- Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt — Mladá Boleslav, Czechia (Recruiting)
- Fakultni nemocnice Olomouc — Olomouc, Czechia (Recruiting)
- Faculty Hospital Ostrava — Ostrava, Czechia (Recruiting)
- Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha — Prague, Czechia (Recruiting)
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- General Hospital of Athens "Korgialeneio - Benakeio" Hellenic Red Cross — Athens, Greece (Recruiting)
- University General Hospital of Heraklion — Heraklion, Greece (Recruiting)
- University Hospital of Larissa — Larissa, Greece (Recruiting)
- Papageorgiou General Hospital of Thessaloniki — Thessaloniki, Greece (Recruiting)
- Erzsebet Furdo Gyogyaszati es Szurokozpont — Miskolc, Hungary (Recruiting)
- Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary (Recruiting)
- Szegedi Tudományegyetem ÁOK — Szeged, Hungary (Recruiting)
- Mater Private Hospital — Dublin, Ireland (Recruiting)
- Bon Secours Hospital, Limerick — Limerick, Ireland (Recruiting)
- Institute of Eye Surgery — Waterford, Ireland (Recruiting)
- Barzilai Medical Center — Ashkelon, Israel (Recruiting)
- Shamir Medical Center Assaf Harofeh — Beer Jacob, Israel (Recruiting)
- Soroka university medical center — Beersheba, Israel (Recruiting)
- Carmel medical center — Haifa, Israel (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
- Pauls Stradins Clinical University hospital — Riga, Latvia (Recruiting)
- Riga East Clinical University hospital Bikernieki — Riga, Latvia (Recruiting)
- Latvian-American Eye Center — Riga, Latvia (Recruiting)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (Recruiting)
- ETZ Elisabeth — Tilburg, Netherlands (Recruiting)
- NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa — Bielsk Podlaski, Poland (Recruiting)
- Centrum Uslug Medycznych OKO-MED — Grudziądz, Poland (Recruiting)
- USK Nr 2 im. WAM w Lodzi, Centralny Szpital Weteranow — Lodz, Poland (Recruiting)
- Szpital Wojewodzki w Poznaniu — Poznan, Poland (Recruiting)
- Pomorski Uniwersytet Medyczny — Szczecin, Poland (Recruiting)
- Szpitale Pomorskie, Szpital Specjalistyczny im. F. Ceynowy — Wejherowo, Poland (Recruiting)
- Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze — Zielona Góra, Poland (Recruiting)
- Espaco Medico Coimbra — Coimbra, Portugal (Recruiting)
- ULS Lisboa Ocidental - Hospital Egas Moniz — Lisbon, Portugal (Recruiting)
- Hospital CUF Tejo — Lisbon, Portugal (Recruiting)
- IMO - Instituto de Microcirurgia Ocular — Lisbon, Portugal (Recruiting)
- Hospital de Sao Joao — Porto, Portugal (Recruiting)
+9 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: MR45586 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.