A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
- Conditions
- Age Related Macular Degeneration
- Interventions
- Registration Number
- NCT02174211
- Lead Sponsor
- King's College Hospital NHS Trust
- Brief Summary
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.
- Detailed Description
This study is a prospective, pharmacokinetic study comparing ranibizumab clearance in two groups of patients; those with and without prior vitrectomy. Additionally it will compare ranibizumab clearance to aflibercept clearance as well as the effect on systemic circulating inflammatory and safety markers. Patients will already be receiving ranibizumab or aflibercept therapy - the injection is itself administered irrespective of their participation in this study and therefore this study will not alter medical management or the choice of therapy.
To estimate ranibizumab and aflibercept clearance, it is important to measure serum concentrations at several intervals within the first 24 hours. Participants will ideally have venous blood sampling at the following times after their ranibizumab or aflibercept injection:
* 1 hour
* 2 hours
* 3 hours
* 4 hours
* 6 hours
* 24 hours
* 2 days
* 4 days
* 1 week\*
* 2 weeks
* 4 weeks\*
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Ranibizumab (Lucentis) Ranibizumab Previous Vitrectomy Arm B: Ranibizumab (Lucentis) Ranibizumab Non-vitrectomised, PVD / no PVD Arm C: Aflibercept (Eylea) Aflibercept Non-vitrectomised, PVD / no PVD
- Primary Outcome Measures
Name Time Method Ranibizumab half-life 12 Months Vitrectomised and non-vitrectomised patients
Aflibercept half-life 12 Months Non-vitrectomised patients only
- Secondary Outcome Measures
Name Time Method Sub-group analysis of the effect of PVD on ranibizumab half-life 12 months Measurement of half-life (drug assay)
The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels. 12 months Assay levels of cytokines and inflammatory/safety markers
Trial Locations
- Locations (1)
King's College Hospital NHS Foundation Trust
🇬🇧London, UK, United Kingdom