Age-related macular degeneration MedDRA version: 17.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Lucentis
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration
Sponsors
King's College Hospital NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of pars plana vitrectomy on the half-life of ranibizumab and to compare the half-life of ranibizumab and aflibercept.;Secondary Objective: Not applicable; Primary end point(s): Half-life of intravitreal ranibizumab in vitrectomised and non-vitrectomised eyes. Half-life of intravitreal aflibercept in non-vitrectomised eyes. . ;Timepoint(s) of evaluation of this end point: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sub-group analysis of the effect of PVD on ranibizumab half-life. The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels. ;Timepoint(s) of evaluation of this end point: 1 month | — |
Countries
United Kingdom
Contacts
Public ContactTim Jackson
King's College Hospital NHS Foundation Trust
Outcome results
None listed