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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,479 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,771-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (61% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.