Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Sponsor
California Retina Consultants
Study ID
NCT02118831
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Blood Sample Collection — BIOLOGICAL
    Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
  • Aflibercept — DRUG
    an intravitreal injection of Aflibercept administered three times on a monthly basis.
  • Bevacizumab — DRUG
    an intravitreal injection of Bevacizumab administered three times on a monthly basis.
  • Ranibizumab — DRUG
    an intravitreal injection of Ranibizumab administered three times on a monthly basis.

Study Details

Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

Key Dates

Start date
Mar 31, 2012
Status verified
Apr 2016
Primary completion
Feb 28, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Aflibercept Blood Sample Collection
    Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
  • Active Comparator: Bevacizumab Blood Sample Collection
    Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
  • Active Comparator: Ranibizumab Blood Sample Collection
    Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.

Primary Outcome Measure

Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses [ Time Frame: Up to 4 months ]

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