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Monoclonal Antibodies

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

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a new treatment for patients with specific eye conditions like nAMD or DME. The treatment has shown positive results in previous studies for reducing swelling and abnormal blood vessel growth in the eye. The study aims to see if healthcare providers can use the new treatment effectively.

Eligible Conditions
  • Diabetic Macular Edema
  • Macular Degeneration

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
3%
Eye irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Faricimab PFS Configuration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,092 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,202 Total Patients Enrolled
~11 spots leftby Dec 2025