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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: Completed Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Thirteen healthcare providers (HCP; seven retina specialists and six assistants) across three sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or
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 |
What the finished NCT05569148 record still lists
NCT05569148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
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 NCT05569148's enrollment target sits among peer trials
35 43rd of 63 higher than 21 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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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
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A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
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A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
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