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

NCT ID: NCT02597855

Last Updated: 2016-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Polypoidal Choroidal Vasculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Aflibercept

Intervention Type DRUG

Total 4 times of intravitreal aflibercept injection was performed

Indocyanine green angiography (intraveonus indocyanine green dye)

Intervention Type DRUG

At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.

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.

Aflibercept

Intervention Type DRUG

Total 4 times of intravitreal aflibercept injection was performed

Indocyanine green angiography (intraveonus indocyanine green dye)

Intervention Type DRUG

At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.

Interventions

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Aflibercept

Total 4 times of intravitreal aflibercept injection was performed

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Eylea

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Min Sagong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeungnam University College of Medicine

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Jeong S, Sagong M. Short-term efficacy of intravitreal aflibercept depending on angiographic classification of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2017 Jun;101(6):758-763. doi: 10.1136/bjophthalmol-2016-309144. Epub 2016 Sep 5.

Reference Type DERIVED
PMID: 27597740 (View on PubMed)

Other Identifiers

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YUMC2015-08-036

Identifier Type: -

Identifier Source: org_study_id

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