NCT02296567

Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients

Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: East Florida Eye Institute · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.

Detailed description

To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
DRUG	Bevacizumab	Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
DRUG	Aflibercept	Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
DRUG	Ranibizumab	Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
DRUG	Bevacizumab	Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
DRUG	Aflibercept	Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
DRUG	Ranibizumab	Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
DRUG	Bevacizumab	Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
DRUG	Aflibercept	Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
OTHER	Control Group	Control group Subjects will no previous anti-VEGF treatment

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-11-20
• Last updated: 2015-08-11

Locations

1 site across 1 country: United States