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NCT05151744 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
A Phase 2 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT05151744: Completed Phase 2 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
NCT05151744 is a Phase 2 study of Diabetic Macular Edema that has completed, run by Hoffmann-La Roche. The registered enrollment target is 187 participants, below the 3,791-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05151744, a Phase 2 study of Diabetic Macular Edema, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision\^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) m
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 |
What the finished NCT05151744 record still lists
NCT05151744 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 3,791-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (95% lower).
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.
NCT05151744 names 20 study sites across 9 states, led by Other, California, Florida.
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.
What interventions are being tested in trial NCT05151744?
The interventions under investigation include: Sham Procedure (OTHER), Ranibizumab (DRUG), Vamikibart (DRUG).
Who is sponsoring clinical trial NCT05151744?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT05151744's enrollment target sits among peer trials
187 23rd of 63 higher than 41 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.
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