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NCT04777201 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,036
- Enrollment target
NCT04777201: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04777201 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,036 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04777201, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,036 participants
- Enrollment target
Study 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.
Primary Outcome
This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting mor
Interventions
- DRUG Faricimab
- OTHER Sham Procedure
- DRUG Anti-VEGF Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,036 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2024-09-03 |
| Phase | Phase 3 |
What the finished NCT04777201 record still lists
NCT04777201 is an interventional study that assigns participants to a tested intervention. Its 1,036 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Faricimab is the first listed.
NCT04777201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04777201 about?
NCT04777201 is a clinical study titled "A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration". 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 ...
What is the current status of trial NCT04777201?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,036 participants. The study started on 2021-04-19. Estimated completion is 2024-09-03.
What interventions are being tested in trial NCT04777201?
The interventions under investigation include: Faricimab (DRUG), Sham Procedure (OTHER), Anti-VEGF Therapy (DRUG).
Who is sponsoring clinical trial NCT04777201?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04777201's enrollment target sits among peer trials
1,036 287th of 2000 higher than 1,714 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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