Evaluating the use of faricimab in treating eye conditions

Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)

Observational Hoffmann-La Roche · NCT06680817

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 typeObservational
Enrollment850 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsfaricimab
Locations59 sites (Graz and 58 other locations)
Trial IDNCT06680817 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

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Neovascular Age-related Macular DegenerationDiabetic Macular Edema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.