NCT01950741

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.

Detailed description

Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.

Conditions

• Exudative Age-related Macular Degeneration
• Polypoidal Choroidal Vasculopathy

Interventions

Type	Name	Description
DRUG	aflibercept	Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2013-09-25
• Last updated: 2016-04-29
• Results posted: 2016-04-29

Locations

8 sites across 1 country: South Korea