A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Collaborator: King's College London
• Treatments: Aflibercept; Ranibizumab

Criteria

Inclusion criteria

• Adults of either sex aged 55 years and older

• Active neovascular AMD in the study eye

• Intravitreal dose of 0.5 mg ranibizumab or 2 mg aflibercept required, as per current clinical guidelines

• Venous access that is sufficient to allow easy blood sampling on a frequent basis

• Able to give written consent

• Willingness to comply with all study procedures

Exclusion criteria

• Myopia greater than 8 dioptres in the study eye

• Axial length of eye under 20mm or over 26mm

• Aphakia in study eye

• Pseudophakia with a defect in the posterior capsule

• Glaucoma in study eye

• Current renal dialysis

• Presence of inflammatory eye conditions, such as uveitis, or systemic conditions likely to elevate CRP.

• Intraocular surgery within 6 months of enrolment, except for routine phacoemulsification cataract surgery that may occur within 4 months of enrolment

• Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab or aflibercept in the study eye. Patients expected to change their anti-VEGF agent during the sampling period are also excluded.

• Known significant allergy to ranibizumab or aflibercept

• Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol or provide informed consent.

• Patients with severe anaemia

• Patients who have received anti-VEGF therapy in either eye within 8 weeks of enrolment, or who are likely to require anti-VEGF treatment in the fellow eye during the course of venous sampling. Note that the final venous sample at 4 weeks can be undertaken on the same day as an anti-VEGF injection, but must be taken prior to any injection.

• Patients presently taking any topical (skin or eye), periocular, intraocular, local or systemic treatment with immunosuppressive or anti-inflammatory agents, such as steroids, steroid sparing agents, and NSAIDs. Patients who have received any of these agents within 2 months prior to enrolment are also excluded, as are those thought likely to receive these medications during the course of venous sampling.