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OpenTrials
Completed

NCT Number: NCT02072408

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

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

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Key information

Conditions

Polypoidal Choroidal Vasculopathy Without Active Polyp

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam, Gyunggi-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug
  • 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 outcomes

  1. Change of best-corrected visual acuity (ETDRS letters)

    Time frame: 1 year

Secondary outcomes

  1. presence of subretinal hemorrhage

    Time frame: during 1 year

    Total number of months when subretinal hemorrhage are detected on fundus photographs.

  2. 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

  3. change of indocyanine green angiography

    Time frame: during 1 year

    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

  4. 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.

  5. safety outcomes

    Time frame: one year

    frequency and severity of ocular adverse event

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Bayer
  • Kim's Eye Hospital
  • Seoul National University Bundang Hospital

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2014
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.