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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,036 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04777201
The ClinicalTrials.gov registry entry for NCT04777201 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,036 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Faricimab is the first listed.
NCT04777201 reports 0 study locations.
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.
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