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

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Drug: Aflibercept; Drug: Indocyanine green angiography (intraveonus indocyanine green dye)

• Registration Number: NCT02597855
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Primary Completion: 2015-12
• Results First Submitted: 2016-03-22
• Results First Submitted QC: 2016-05-10
• Results First Posted: 2016-06-17
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Study Completion: 2016-08
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 polypoidal choroidal vasculopathy	Indocyanine green angiography (intraveonus indocyanine green dye)	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	Indocyanine green angiography (intraveonus indocyanine green dye)	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 1 polypoidal choroidal vasculopathy	Aflibercept	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	Aflibercept	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.

Primary Outcome Measures

Name	Time	Method
Regression Rate of Polyp on Indocyanine Green Angiography	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 Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	baseline, 3 months, and 6 monthsc	Best corrected visual acuity assessed at baseline, 3 months, and 6 months

Trial Locations

Locations (1)

Yeungnam University College of Medicine; 🇰🇷 Daegu, Korea, Republic of