Sierra Eye Associates | Reno, NV
Status and phase
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About
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.
Enrollment
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Inclusion and exclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
1,036 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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