Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

California Retina Consultants

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Age-related Macular Degeneration

Treatments: Drug: Bevacizumab; Drug: Ranibizumab; Biological: Blood Sample Collection; Drug: Aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02118831

ML28032

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent for participation in this study
• Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection

Exclusion criteria

• Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
• Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
• Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
• Subjects with history of vitrectomy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

Aflibercept Blood Sample Collection

Active Comparator group

Description:

Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.

Treatment:

Drug: Aflibercept

Biological: Blood Sample Collection

Bevacizumab Blood Sample Collection

Active Comparator group

Description:

Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.

Treatment:

Drug: Bevacizumab

Biological: Blood Sample Collection

Ranibizumab Blood Sample Collection

Active Comparator group

Description:

Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.

Treatment:

Drug: Ranibizumab

Biological: Blood Sample Collection