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Monoclonal Antibodies

Faricimab PFS Configuration for Age-Related Macular Degeneration

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing and able to comply with clinic visits and study-related procedures

For female patients of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

Study Summary

This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events occurring during the 7-day study reporting period will be summarized.

Eligible Conditions

Age-Related Macular Degeneration
Diabetic Macular Edema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration

Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration

Side effects data

From 2022 Phase 3 trial • 35 Patients • NCT05569148

Eye irritation

100%

80%

60%

40%

20%

Study treatment Arm

Faricimab PFS Configuration

Trial Design

1Treatment groups

Experimental Treatment

Group I: Faricimab PFS ConfigurationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Faricimab PFS Configuration

2022

Completed Phase 3

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,089,030 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,198 Previous Clinical Trials

888,410 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients enroll in this trial at this time?

"Yes, this is an ongoing study that was initially posted on October 17th, 2020. The listing was most recently updated on October 28th, 2020. At the moment, the trial is seeking to enroll a total of 35 patients from 3 clinical sites."

Answered by AI

What is the most updated information regarding the FDA's stance on Faricimab PFS Configuration?

"Although this is a Phase 3 trial, meaning that safety has been supported by some data, there have been multiple rounds of data collected that support the safety of Faricimab PFS Configuration. Therefore, our team has given it a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe

2022. "A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05569148.