Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy

Samsung Medical Center3 sites in 1 country46 target enrollmentFebruary 2014

ConditionsPolypoidal Choroidal Vasculopathy Without Active Polyp

Interventionsaflibercept

Drugsaflibercept

Overview

Phase: Phase 4
Intervention: aflibercept
Conditions: Polypoidal Choroidal Vasculopathy Without Active Polyp
Sponsor: Samsung Medical Center
Enrollment: 46
Locations: 3
Primary Endpoint: Change of best-corrected visual acuity (ETDRS letters)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

November 2, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•polypoidal choroidal vasculopathy without active polyp
•decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

Exclusion Criteria

•polypoidal choroidal vasculopathy with active polyp
•previous photodynamic therapy more than three times
•anti-VEGF injection within one month
•photodynamic therapy or intraocular steroid treatment within three months

Arms & Interventions

polypoidal choroidal vasculopathy without polyp

Intervention: aflibercept

Outcomes

Primary Outcomes

Change of best-corrected visual acuity (ETDRS letters)

Time Frame: 1 year

Secondary Outcomes

safety outcomes(one year)
presence of subretinal hemorrhage(during 1 year)
change of indocyanine green angiography(during 1 year)
Number of eyes which need rescue treatment (photodynamic therapy)(during 1 year)
presence of fluid in macula evidenced by optical coherence tomography(during 1 year)