Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy

Overview

To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Detailed Description

The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.

Interventions

  • Drug: Aflibercept
    • Total 4 times of intravitreal aflibercept injection was performed
  • Drug: Indocyanine green angiography (intraveonus indocyanine green dye)
    • At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.

Arms, Groups and Cohorts

  • Type 1 polypoidal choroidal vasculopathy
    • Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
  • Type 2 polypoidal choroidal vasculopathy
    • Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.

Clinical Trial Outcome Measures

Primary Measures

  • Regression Rate of Polyp on Indocyanine Green Angiography
    • Time Frame: 3 months
    • Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.

Secondary Measures

  • Best Corrected Visual Acuity
    • Time Frame: baseline, 3 months, and 6 monthsc
    • Best corrected visual acuity assessed at baseline, 3 months, and 6 months

Participating in This Clinical Trial

Inclusion Criteria

1. symptomatic typical PCV accompanying branch vascular network involving subfoveal area

2. signed informed consent; and

3. over 6 months follow-up period after enrollment.

Exclusion Criteria

1. retinal diseases other than PCV

2. extrafoveal PCV not involving subfoveal area

3. massive subretinal hemorrhage blocking polypoidal lesion on ICGA

4. severe media opacity such as senile cataract

5. previous history of intravitreal injection

6. previous intraocular surgery history except cataract surgery which was done more than 3 months.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yeungnam University College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Min Sagong, Assistant Professor – Yeungnam University College of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.