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

Primary Purpose

Polypoidal Choroidal Vasculopathy Without Active Polyp

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aflibercept
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy Without Active Polyp

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Konyang University Kim's Eye Hospital
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

polypoidal choroidal vasculopathy without polyp

Arm Description

Outcomes

Primary Outcome Measures

Change of best-corrected visual acuity (ETDRS letters)

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2014
Last Updated
September 2, 2018
Sponsor
Samsung Medical Center
Collaborators
Seoul National University Bundang Hospital, Kim's Eye Hospital, Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02072408
Brief Title
Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
November 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Seoul National University Bundang Hospital, Kim's Eye Hospital, Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy Without Active Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polypoidal choroidal vasculopathy without polyp
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
aflibercept
Intervention Description
Three monthly intravitreal aflibercept (2mg) injections Five bimonthly intravitreal aflibercept (2mg) injections 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
Primary Outcome Measure Information:
Title
Change of best-corrected visual acuity (ETDRS letters)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
presence of subretinal hemorrhage
Description
Total number of months when subretinal hemorrhage are detected on fundus photographs.
Time Frame
during 1 year
Title
presence of fluid in macula evidenced by optical coherence tomography
Description
Total number of months when fluid in macula are detected on optical coherence tomography
Time Frame
during 1 year
Title
change of indocyanine green angiography
Description
Change of indocyanine green angiography will include followings New appearance of polypoidal structure Any change in size of the greatest linear dimension of lesion Any change in size and activity of branching vascular network
Time Frame
during 1 year
Title
Number of eyes which need rescue treatment (photodynamic therapy)
Description
In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.
Time Frame
during 1 year
Title
safety outcomes
Description
frequency and severity of ocular adverse event
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
Country
Korea, Republic of
Facility Name
Konyang University Kim's Eye Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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