WR42221 - Ranibizumab with PDS in Wet AMD
Research type
Research Study
Full title
A PHASE IIIb, GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR−MASKED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (VELODROME)
IRAS ID
294986
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-001313-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 29 days
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 23.47 million in 2010 to 80.44 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. Frequent intravitreal injections in clinical practice can be a substantial burden on patients,caregivers and the health care system.Ranibizumab is a recombinant, humanized, monoclonal antibody that binds to and inhibits the biologic activity of VEGF-A that is administered by intravitreal administration.
The PDS (Port Delivery System) is an innovative, investigational, intraocular drug delivery system that allows clinicians to use ranibizumab with a continuous drug delivery profile.This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab 100mg/ml delivered via the PDS every 36 weeks(Q36W)compared with every 24 weeks(Q24W).Enrolment of approximately 442 patients globally is planned to randomise 354 patients with nAMD. All patients will have the PDS(pre-filled with ranibizumab) implanted, then at week 24 patients who have not met Disease Activity Criteria will be randomised to either Q36W refill or Q24W refill.Those who do meet the criteria will exit the study and be offered an OLE study.
The study will last approx. 18-22 months for each individual patient.There will be approximately 40 patients recruited at 10 UK sites
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1.0 dated 15-Feb-2021REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0120
Date of REC Opinion
22 Jun 2021
REC opinion
Further Information Favourable Opinion