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

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.

Timeline

Start

2022-10-17

Primary completion

2022-11-10

Completion

2022-11-10

Publications

• Barakat MR, Kwong HM Jr, Marcon G, O'Leary OE, Paris LP, Schneider P, Tang Y, Graff JM. Human Factors Studies to Assess the Usability of the Faricimab Prefilled Syringe. Clin Ophthalmol. 2025 Feb 6;19:395-406. doi: 10.2147/OPTH.S503060. eCollection 2025.

Drugs

Indications