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NCT03622593 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 951
- Enrollment target
NCT03622593: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03622593 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 951 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03622593, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 951 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Primary Outcome
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters),
Interventions
- PROCEDURE Sham Procedure
- DRUG Faricimab
- DRUG Aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 951 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 3 |
What the finished NCT03622593 record still lists
NCT03622593 is an interventional study that assigns participants to a tested intervention. The registered 951 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT03622593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03622593 about?
NCT03622593 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema". This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
What is the current status of trial NCT03622593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 951 participants. The study started on 2018-10-09. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT03622593?
The interventions under investigation include: Sham Procedure (PROCEDURE), Faricimab (DRUG), Aflibercept (DRUG).
Who is sponsoring clinical trial NCT03622593?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03622593's enrollment target sits among peer trials
951 333rd of 2000 higher than 1,668 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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