GR40549 - OLE Ranibizumab with PDS in nAMD
Research type
Research Study
Full title
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (PORTAL)
IRAS ID
1004993
Contact name
Micaela Rocco
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd
Eudract number
2020-004427-16
Research summary
Neovascular age-related macular degeneration (nAMD) is a form of advanced AMD that causes rapid and severe visual loss, and remains a leading cause of visual impairment in the elderly. In the next 30 years, the global population aged 60 years and older is projected to increase dramatically, resulting in a significant increase in the prevalence of nAMD from 23 million in 2010 to 80 million by 2050.
Although nAMD is comparatively uncommon, it accounted for the majority of cases of severe vision loss from AMD prior to the development of anti-vascular endothelial growth factor (anti-VEGF) therapy. Treatment of nAMD was significantly impacted by the introduction of anti-VEGF therapy, however a key challenge with this treatment is the requirement for frequent and long-term administration. Under-treatment of nAMD in clinical practice reflects the burden of frequent therapy on patients, caregivers, and the healthcare system.
Ranibizumab is a recombinant, humanised, monoclonal antibody that binds to and inhibits the biologic activity of VEGF-A that is administered intravitreally.
The Port Delivery System with ranibizumab (PDS) is an innovative, intraocular drug delivery system that allows physicians to use ranibizumab with a continuous drug delivery profile.
This study will evaluate the long-term safety and tolerability of ranibizumab delivered via PDS in patients with nAMD who have participated in one of the parent studies listed in the protocol. At this time the only parent study running in the UK is WR42221.
The study will last approximately 36 months for each individual patient, who will receive refills of the implant either every 24 or 36 weeks. The number of patients that will enrol into GR40549 will depend on the number of patients recruited into WR42221 (currently 40 patients are expected to be recruited).
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1.0 dated 10-May-2022REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0167
Date of REC Opinion
1 Sep 2022
REC opinion
Further Information Favourable Opinion