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RHONE

Title A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Diabetic Macular Edema
Therapeutic Area Diabetic Macular Edema
Principal Investigator Caroline Baumal, MD
Min Age 18 Years
Gender All
Contact Nancy Gee
617 636 5489
ngee@tuftsmedicalcenter.org

Overview

This long-term extension (LTE) study will evaluate the long-term safety, tolerability, and efficacy of intravitreal (IVT) faricimab in patients with diabetic macular edema who have completed either of the Phase III (GR40349 or GR40398) studies. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed

Study Details

Inclusion Criteria

  • Previous participation in the RHINE study
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods

Exclusion Criteria

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final ITV injection of faricimab
  • Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections

Study Requirements

You will have monthly, masked study visits for the first four months of the study (Day 1 through to Week 16), where you and your physicians will be masked to the treatment interval. After the masked phase, you will only be required to attend the clinic when you require your faricimab 6 mg study treatment.