Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Diabetic Macular Edema Clinical Trial

Official title:

Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118831
• Other study ID #: ML28032
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 15, 2014
• Last updated: April 17, 2014
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: California Retina Consultants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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 levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 reitnal 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 reitnal vein occlusion

• Subjects with history of vitrectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Aflibercept
Subjects will receive intravitreal aflibercept as part of their routine medical care.
• Bevacizumab
Subjects will receive intravitreal bevacizumab as part of their routine medical care.
• Ranibizumab
Subjects will receive intravitreal ranibizumab injections as part of their routine medical care.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
California Retina Consultants

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Pharmacokinetics Following Treatment	Serum levels of ranibizumab, bevacizumab or aflibercept will be measured up to 4 months following standard care treatment.	Up to 4 months	No
Secondary	Change in serum and plasma levels of free vascular endothelial growth factor	Serum and plasma levels of free vascular endothelial growth factor will be measured up to 4 months following treatment.	Up to 4 months	No