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

July 18, 2016 updated by: Min Sagong, Yeungnam University College of Medicine
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

29

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

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

43 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients were recruited from the retinal clinic of the Yeungnam university hospital. Recruitment started on October 01 2015 to March 31 2016.

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Aflibercept
Total 4 times of intravitreal aflibercept injection was performed
Other Names:
  • Eylea
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.
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.
Drug: Aflibercept
Total 4 times of intravitreal aflibercept injection was performed
Other Names:
  • Eylea
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Yeungnam University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUMC2015-08-036

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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