Differentiation between ranibizumab IVT and PFS
Research type
Research Study
Full title
Time differentiation for intravitreal treatments (IVT) between ranibizumab (Lucentis®) vial and ranibizumab (Lucentis®) pre-filled syringe (PFS) in real life clinical practice
IRAS ID
190147
Contact name
Fosca De Iorio
Contact email
Sponsor organisation
Novartis Pharmace
Duration of Study in the UK
0 years, 0 months, 31 days
Research summary
In recent years, there has been a significant increase in the number of patients requiring and eligible for treatment of retinal conditions such as neovascular age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema (DME), visual impairment due to macular edema following retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularisation secondary to pathologic myopia (mCNV). nAMD and DME are responsible for more than half of registered severe sight impairment worldwide. The increase in incidence has been driven both by the aging population and the increase in treatment due to the introduction of new treatment modalities such as anti-VEGF therapies. Whilst more patients are eligible compared to previous interventions, the superior treatment outcomes achieved with anti-VEGF therapies do require more frequent administration and follow up. This has meant a large increase in clinical workload for hospitals.
For that reason, clinical processes need to evolve so they can provide a fast and efficient service for patients treated for their nAMD, DME, RVO and mCNV.
Retinal specialists have highlighted several key opportunities with the current ranibizumab (RBZ) posology and injection procedure, with a large number reporting that the preparation of the RBZ intravitreal injection is a time consuming process for them and/or their clinic staff. There is therefore the potential to minimize the injection procedure time/improve the convenience by offering a RBZ pre-filled syringe (PFS).
Lucentis® solution for injection in PFS was granted approval in Europe on 24th October 2013. The PFS was added as a new presentation to the existing presentation in vials. The solutions for injection in the PFS and in the vials are identical in terms of formulation. The main advantage of the PFS is that several preparation steps are saved leading to a shorter injection preparatory process.
This proposed study will assess the new process and collect the time spent preparing the injection with either the RBZ vial or RBZ PFS irrespective of the eye disease treated in real life clinical setting in order to quantify the potential time saved. No other time except the preparation time will be assessed in that study.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0461
Date of REC Opinion
1 Dec 2015
REC opinion
Favourable Opinion