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Faricimab PFS Configuration for Age-Related Macular Degeneration
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.
- Age-Related Macular Degeneration
- Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 35 Patients • NCT05569148Trial Design
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Frequently Asked Questions
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."
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."
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