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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 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.

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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.

Conditions Studied

Diabetic Macular Edema

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

FieldValue
Enrollment Target 187 participants
Start Date 2021-12-17
Est. Completion 2024-10-01
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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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, categorized as Phase 2. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,791-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (95% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.