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AVONELLE


Title A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
Therapeutic Area Macular Degeneration
Principal Investigator Caroline Baumal, MD
Min Age 18 Years
Max Age 100 Years
Gender Any
Contact Nancy Gee
617-636-5489
ngee@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04777201

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 GR40306 (TENAYA) study. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed.

Study Details

Inclusion Criteria

  • Previous participation in the TENAYA 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 intiial 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 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 three months of the study (Day 1 through to Week 12), 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.