NCT05569148

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-related Macular Degeneration
• Diabetic Macular Edema

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Faricimab PFS Configuration	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.

Timeline

• Start date: 2022-10-17
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2022-10-06
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study