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

Sponsor
King's College Hospital NHS Trust
Study ID
NCT02174211
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of ranibizumab
  • Aflibercept — DRUG
    Intravitreal injection of aflibercept

Study Details

To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.

Key Dates

Start date
Jun 30, 2014
Status verified
Apr 2021
Primary completion
Nov 30, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Ranibizumab (Lucentis)
    Previous Vitrectomy
  • Active Comparator: Arm B: Ranibizumab (Lucentis)
    Non-vitrectomised, PVD / no PVD
  • Active Comparator: Arm C: Aflibercept (Eylea)
    Non-vitrectomised, PVD / no PVD

Primary Outcome Measure

Ranibizumab half-life [ Time Frame: 12 Months ]

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