NCT02257632

Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration

A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.

Detailed description

A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.

Conditions

• Wet Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.5 mg	Administered as an intravitreal injection
DRUG	Aflibercept 2 mg	Administered as an intravitreal injection

Timeline

• Start date: 2015-04-08
• Primary completion: 2017-03-20
• Completion: 2017-06-08
• First posted: 2014-10-06
• Last updated: 2019-05-07
• Results posted: 2019-05-07

Locations

6 sites across 1 country: Germany