GR40306 (TENAYA): A study of faricimab in nAMD
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)
IRAS ID
257111
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2018-002152-32
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Neovascular age-related macular degeneration (nAMD), also known as "wet AMD", is a form of advanced AMD that causes rapid and severe visual loss and remains a leading cause of visual impairment in the elderly.
The treatment of nAMD has been markedly improved by anti-vascular endothelial growth factor (anti-VEGF) agents, with their widely recognized ability to restore vision. However, their frequent and long-term administration to maintain vision gains remain a key challenge.
Faricimab is a novel humanized bispecific IgG1 monoclonal antibody that selectively blocks two important pathways that are thought to be involved in nAMD: VEGF-A and angiopoietin-2.
This is a Phase III, multicentre, randomized, active comparator-controlled, double-masked, parallel-group, 100-week study to investigate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at up to 16-week intervals to treatment-naive patients with nAMD.
Approximately 640 patients will be randomized into the study globally in a 1:1 ratio to one of two treatment arms (6mg faricimab up to every 16 weeks or comparator Aflibercept up to every 8 week).
In the UK, it is anticipated that 60 patients will be recruited from 15 participating centres.
The study is sponsored by F. Hoffman-La Roche
Research Summary; Version Number 1.0 and 20 Nov 2018
REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0047
Date of REC Opinion
21 Mar 2019
REC opinion
Further Information Favourable Opinion