Health TrialsbyHealthPanel

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

ConditionsNeovascular Age-related Macular DegenerationDiabetic Macular Edema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial population

Patients being treated with faricimab approved for nAMD and DME in real-world, routine clinical practice.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Faricimab

    Drug

    Faricimab will be administered as per local clinical practice and local labeling.

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Faricimab for nAMD1 intervention
Group B: Cohort 2: Faricimab for DME1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Index Date and 12 months

Secondary outcomes

1

Change in Visual Acuity from Index Date to 3, 6, and 24 Months

Time frame
Index Date and 3, 6, and 24 months
2

Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months

Time frame
Index Date and 3, 6, 12, and 24 months
3

Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time

Time frame
Index Date and 3, 6, 12, and 24 months
4

Number of Faricimab Intravitreal Injections per Eye per Year

Time frame
12 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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