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

September 2, 2018 updated by: Samsung Medical Center
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Konyang University Kim's Eye Hospital
    • Gyunggi-do
      • Seongnam, Gyunggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: polypoidal choroidal vasculopathy without polyp
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of best-corrected visual acuity (ETDRS letters)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of subretinal hemorrhage
Time Frame: during 1 year
Total number of months when subretinal hemorrhage are detected on fundus photographs.
during 1 year
presence of fluid in macula evidenced by optical coherence tomography
Time Frame: during 1 year
Total number of months when fluid in macula are detected on optical coherence tomography
during 1 year
change of indocyanine green angiography
Time Frame: 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
during 1 year
Number of eyes which need rescue treatment (photodynamic therapy)
Time Frame: during 1 year
In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.
during 1 year
safety outcomes
Time Frame: one year
frequency and severity of ocular adverse event
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Bayer
Seoul National University Bundang Hospital
Kim's Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

November 2, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 2, 2018

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-10-044-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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