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A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

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Trial Profile

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2024

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At a glance

  • Drugs Faricimab (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms RHINE
  • Sponsors Roche

    • Most Recent Events

    • 01 Nov 2024 Results evaluating the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME and baseline BCVA of 20/50 or worse enrolled in faricimab phase III trials published in the Ophthalmology
    • 04 Jul 2024 According to a Genentech media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
    • 01 Jun 2024 Results evaluating the 2-year efficacy, durability, and safety of Faricimab up to every-16-week dosing in the YOSEMITE and RHINE trials (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) published in the Ophthalmology.

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