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A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
NCT04432831 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.
Conditions Studied
Interventions
- DRUG Faricimab
- OTHER Sham Procedure
Study Locations (20)
California
- California Retina Consultants. — Bakersfield
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retinal Diagnostic Center — Campbell
- The Retina Partners — Encino
- Eye Medical Center — Fresno
- Retina Consultants of Orange County — Fullerton
- Southern California Permanente Medical Group — Los Angeles
- Northern California Retina Vitreous Associates — Mountain View
- East Bay Retina Consultants — Oakland
- Southern CA Desert Retina Cons — Palm Desert
- California Eye Specialists Medical group Inc. — Pasadena
- Retina Consultants, San Diego — Poway
- Retina Consultants of Southern California — Redlands
- Retinal Consultants Med Group — Sacramento
- West Coast Retina Medical Group — San Francisco
- Orange County Retina Med Group — Santa Ana
Arizona
- Barnet Dulaney Perkins Eye Center — Mesa
- Retinal Research Institute, LLC — Phoenix
- Arizona Retina and Vitreous Consultants — Phoenix
- Retina Associates Southwest PC — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,479 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04432831
The ClinicalTrials.gov registry entry for NCT04432831 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions — of which Faricimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04432831 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04432831 about?
NCT04432831 is a clinical study titled "A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema". This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT...
What is the current status of trial NCT04432831?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,479 participants. The study started on 2020-08-05. Estimated completion is 2023-10-11.
What conditions does trial NCT04432831 study?
This clinical trial studies the following conditions: Diabetic Macular Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04432831?
The interventions under investigation include: Faricimab (DRUG), Sham Procedure (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04432831?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04432831 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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