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

NCT ID: NCT02072408

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-11-02

Brief Summary

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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

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Conditions

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Polypoidal Choroidal Vasculopathy Without Active Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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polypoidal choroidal vasculopathy without polyp

Group Type EXPERIMENTAL

aflibercept

Intervention Type DRUG

1. Three monthly intravitreal aflibercept (2mg) injections
2. Five bimonthly intravitreal aflibercept (2mg) injections
3. Rescue treatment: Verteporfin photodynamic therapy

* Loss of five ETDRS letters or one Snellen line of vision from baseline
* Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection
* Presence of active polyp on indocyanine green angiography

Interventions

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aflibercept

1. Three monthly intravitreal aflibercept (2mg) injections
2. Five bimonthly intravitreal aflibercept (2mg) injections
3. Rescue treatment: Verteporfin photodynamic therapy

* Loss of five ETDRS letters or one Snellen line of vision from baseline
* Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection
* Presence of active polyp on indocyanine green angiography

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Kim's Eye Hospital

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Site Status

Konyang University Kim's Eye Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-10-044-002

Identifier Type: -

Identifier Source: org_study_id

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