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A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
NCT05151744 · View on ClinicalTrials.gov ↗
Study Summary
Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.
Conditions Studied
Interventions
- OTHER Sham Procedure
- DRUG Ranibizumab
- DRUG Vamikibart
Study Locations (20)
Other
- Organizacion Medica de Investigacion — Buenos Aires
- Centro Oftalmológico Dr. Charles S.A. — Capital Federal
- Oftalmos — Capital Federal
- Buenos Aires Mácula — Ciudad Autonoma Buenos Aires
- Grupo Laser Vision — Rosario
- Rambam Medical Center — Haifa
- Hadassah MC — Jerusalem
California
- Win Retina — Arcadia
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
- Bay Area Retina Associates — Walnut Creek
Florida
- Florida Eye Associates — Melbourne
- Retina Vitreous Associates of Florida — Tampa
Texas
- Texas Retina Associates — Arlington
- Retina Consultants of Texas — Bellaire
Ontario
- Retina Institute of Ottawa — Ottawa
- Toronto Retina Institute — Toronto
Maryland
- Cumberland Valley Retina Consultants — Hagerstown
Mississippi
- Deep Blue Retina PLLC — Southaven
Oregon
- Verum Research LLC — Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05151744
The ClinicalTrials.gov registry entry for NCT05151744 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions — of which Sham Procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05151744 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05151744 about?
NCT05151744 is a clinical study titled "A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema". Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, r...
What is the current status of trial NCT05151744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2021-12-17. Estimated completion is 2024-10-01.
What conditions does trial NCT05151744 study?
This clinical trial studies the following conditions: Diabetic Macular Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05151744?
The interventions under investigation include: Sham Procedure (OTHER), Ranibizumab (DRUG), Vamikibart (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05151744?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05151744 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Mississippi, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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