NCT04777201

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,036 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.
OTHER	Sham Procedure	The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.
DRUG	Anti-VEGF Therapy	At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Timeline

• Start date: 2021-04-19
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2021-03-02
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

251 sites across 27 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study