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

NCT06680817

Active Not RecruitingN/A

Sponsor: Hoffmann-La Roche

Conditions: Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

Interventions: Faricimab

Countries: Austria, Bulgaria, Czechia, Finland, Greece, Hungary, Ireland, Israel

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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)
Locations (59)
  • Graz, Austria
  • Innsbruck, Austria
  • Linz, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Liberec, Czechia
  • Mladá Boleslav, Czechia
  • Olomouc, Czechia
  • Ostrava, Czechia
  • Prague, Czechia
  • Helsinki, Finland
  • Tampere, Finland
  • Athens, Greece
  • Heraklion, Greece
  • Larissa, Greece
  • Thessaloniki, Greece
  • Miskolc, Hungary
  • Pécs, Hungary
  • Szeged, Hungary
  • Dublin, Ireland
  • Limerick, Ireland
  • Waterford, Ireland
  • Ashkelon, Israel
  • Beer Jacob, Israel
  • + 29 more on CT.gov