CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 35 enrolled
Drug / intervention
Faricimab PFS Configurationcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05569148
NCT05569148Phase 3Completed
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A Phase IIIb, Open-Label, Single-Arm Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the 6-mg Faricimab Prefilled Syringe

Hoffmann-La Roche·interventional·Posted Oct 6, 2022·Updated Oct 10, 2023

In Brief

A Phase 3 clinical trial evaluating Faricimab PFS Configuration for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema. Completed, enrolled 35 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-related Macular Degeneration, Diabetic Macular Edema
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedOct 6, 2022
Enrollment StartOct 17, 2022
Primary CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 3.7 years ago

Interventions

Faricimab PFS Configurationcombination

Participants will receive a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation delivered via prefilled syringe (PFS) with a co-packaged injection filter needle.