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NCT05569148 · ClinicalTrials.gov registry record · Phase 3
A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
A Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
- 3
- Study locations
NCT05569148 is a Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration that has completed, run by Hoffmann-La Roche. The registered enrollment target is 35 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT05569148, a Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
- 3
- Study locations
Study Summary
This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events occurring during the 7-day study reporting period will be summarized.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Faricimab PFS Configuration
Study Locations (3)
Arizona
- Barnet Dulaney Perkins Eye Center - Mesa
- Associated Retina Consultants - Phoenix
- Retinal Consultants of Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-10-17 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05569148
The ClinicalTrials.gov registry entry for NCT05569148 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Faricimab PFS Configuration is the first listed.
NCT05569148 reports 3 study locations spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT05569148 about?
NCT05569148 is a clinical study titled "A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe". This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to p...
What is the current status of trial NCT05569148?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2022-10-17. Estimated completion is 2022-11-10.
What conditions does trial NCT05569148 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT05569148?
The interventions under investigation include: Faricimab PFS Configuration (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05569148?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05569148 being conducted?
This trial has 3 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.