GR42691: Long-term safety extension study of faricimab in patients with nAMD (AVONELLE-X)
Research type
Research Study
Full 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
IRAS ID
1003688
Sponsor organisation
F.Hoffmann La-Roche Ltd
Eudract number
2020-004523-16
Clinicaltrials.gov Identifier
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 current standard of care requires frequent and long term administration of anti-VEGF by intravitreal (IVT) injection (into the eye) to maintain vision gains, which imposes a significant burden on patients, caregivers and the healthcare system. New treatments that target additional pathways and lead to reduced burden of IVT injections are needed to address high, unmet medical need in patients with nAMD.
Faricimab is a monoclonal antibody that selectively binds to two proteins (Ang-2 and VEGF-A) with early studies showing the potential to extend the treatment interval to maintain vision.
This study will evaluate the long term safety and tolerability of faricimab 6mg administered by IVT injection at a personalised treatment interval (PTI) in patients with nAMD who have completed either of the Phase III (GR40306 or GR40844) studies. Eligible patients who choose to enroll into the LTE study will have monthly, masked, study visits for the first 3 months of the study, followed by an open-label design in which participants will only be required to attend study visits at which faricimab is to be administered, depending on the condition of the eye. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.
Approximately 1280 patients are expected to participate in this extension study globally, with an anticipated 58 participants being recruited from 15 sites in the UK.
The study is sponsored by F. Hoffmann La Roche.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0109
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion