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NCT05151731 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 394
- Enrollment target
NCT05151731: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT05151731 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 394 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05151731, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 394 participants
- Enrollment target
Study Summary
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
Primary Outcome
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study \[ETDRS\] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual ac
Interventions
- OTHER Sham Procedure
- DRUG Ranibizumab
- DRUG Vamikibart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2021-12-31 |
| Est. Completion | 2025-04-21 |
| Phase | Phase 2 |
What the finished NCT05151731 record still lists
NCT05151731 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT05151731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05151731 about?
NCT05151731 is a clinical study titled "A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema". Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will b...
What is the current status of trial NCT05151731?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 394 participants. The study started on 2021-12-31. Estimated completion is 2025-04-21.
What interventions are being tested in trial NCT05151731?
The interventions under investigation include: Sham Procedure (OTHER), Ranibizumab (DRUG), Vamikibart (DRUG).
Who is sponsoring clinical trial NCT05151731?
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 NCT05151731's enrollment target sits among peer trials
394 103rd of 2000 higher than 1,897 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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