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

Phase 4

Completed

• Conditions: Polypoidal Choroidal Vasculopathy Without Active Polyp
• Interventions: Drug: aflibercept

• Registration Number: NCT02072408
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-02
• Study Start: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Primary Completion: 2017-11-02
• Study Completion: 2017-11-02
• Last Update Submitted: 2018-09-02
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
polypoidal choroidal vasculopathy without polyp	aflibercept	-

Primary Outcome Measures

Name	Time	Method
Change of best-corrected visual acuity (ETDRS letters)	1 year

Secondary Outcome Measures

Name	Time	Method
safety outcomes	one year	frequency and severity of ocular adverse event
presence of subretinal hemorrhage	during 1 year	Total number of months when subretinal hemorrhage are detected on fundus photographs.
change of indocyanine green angiography	during 1 year	Change of indocyanine green angiography will include followings; 1. New appearance of polypoidal structure; 2. Any change in size of the greatest linear dimension of lesion; 3. Any change in size and activity of branching vascular network
Number of eyes which need rescue treatment (photodynamic therapy)	during 1 year	In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.
presence of fluid in macula evidenced by optical coherence tomography	during 1 year	Total number of months when fluid in macula are detected on optical coherence tomography

Trial Locations

Locations (3)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of

Konyang University Kim's Eye Hospital; 🇰🇷 Seoul, Korea, Republic of