MR42410 - PDS with Ranibizumab vs Aflibercept
Research type
Research Study
Full title
A PHASE IIIB, MULTICENTER, RANDOMIZED,VISUAL ASSESSOR-MASKED STUDY OF THEEFFECTIVENESS AND SAFETY OF A 36-WEEKREFILL REGIMEN FOR THE PORT DELIVERYSYSTEM WITH RANIBIZUMAB VS AFLIBERCEPTTREAT & EXTEND IN SUBJECTS WITHNEOVASCULAR AGE-RELATED MACULARDEGENERATION (DIAGRID)
IRAS ID
1004778
Contact name
Micaela Rocco
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd
Eudract number
2021-003226-71
Clinicaltrials.gov Identifier
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.
nAMD 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. Frequent intravitreal injection therapy for nAMD in clinical practice can be a substantial burden on individuals with nAMD, caregivers, and the health care system.
Ranibizumab is a recombinant, humanised, monoclonal antibody that binds to and inhibits the biologic activity of VEGF-A and is administered by intravitreal administration.
The PDS (Port Delivery System) is an innovative, investigational, intraocular drug delivery system that allows clinicians to use (a customised formulation of) ranibizumab with a continuous drug delivery profile.
This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept T&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).
The study will last approx. 90 weeks for each individual patient. There will be approximately 32 patients recruited at 9 UK sites.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1.0 dated 24-Feb-2022REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0131
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion