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NCT04432831 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
A Phase 3 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,479
- Enrollment target
- 20
- Study locations
NCT04432831: Completed Phase 3 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
NCT04432831 is a Phase 3 study of Diabetic Macular Edema that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,479 participants, below the 3,771-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04432831, a Phase 3 study of Diabetic Macular Edema, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,479 participants
- Enrollment target
- 20
- Study locations
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.
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
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 |
What the finished NCT04432831 record still lists
NCT04432831 is an interventional study that assigns participants to a tested intervention. Its 1,479 participants enrollment target places it among the larger protocols in the corpus, below the 3,771-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (61% lower).
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.
NCT04432831 names 20 study sites across 2 states, led by California, Arizona.
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.
What interventions are being tested in trial NCT04432831?
The interventions under investigation include: Faricimab (DRUG), Sham Procedure (OTHER).
Who is sponsoring clinical trial NCT04432831?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04432831's enrollment target sits among peer trials
1,479 3rd of 63 higher than 61 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema 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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