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)
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)
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.
Inclusion Criteria for the Main Study:
Inclusion Criteria for the Substudy:
Exclusion Criteria for the Main Study:
Exclusion Criteria for the Substudy:
In addition to the exclusion criteria specified in the main Study GR42691, patients will be excluded from this substudy if they meet any of the following exclusion criteria:
Exclusion Criteria in Either Eye for the Substudy:
CABA, 1023, Argentina
Capital Federal, C1116, Argentina
Capital Federal, C1120AAN, Argentina
Ciudad Autonoma Buenos Aires, C1061AAE, Argentina
Vancouver, British Columbia V5Z 1M9, Canada
Debrecem, 4032, Hungary
Rome, Lazio 00198, Italy
Milan, Lombardy 20100, Italy
Hokkaido, 060-8604, Japan
Hokkaido, 078-8510, Japan
Del. Cuauhtemoc, Mexico CITY (federal District) 06760, Mexico
Monterrey Nuevo LEON, Nuevo León 64060, Mexico
Gda?sk, 80-402, Poland
Gda?sk, 80-809, Poland
Krakow, 31-501, Poland
Cheboksary, Mariy-El Republic 428000, Russia
Moscow, Moscow Oblast 119435, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Novosibirsk, 630096, Russia
San Cugat Del Valles, Barcelona 08195, Spain
Gloucestershire, GL1 3NN, United Kingdom