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

NCT02597855 | Unknown Results

• 1 other identifier: YUMC2015-08-036
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Regression Rate of Polyp on Indocyanine Green Angiography

  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 Outcomes (1)

• Best Corrected Visual Acuity

  baseline, 3 months, and 6 monthsc

Study Arms (2)

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; Drug: Indocyanine green angiography (intraveonus indocyanine green dye)

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; Drug: Indocyanine green angiography (intraveonus indocyanine green dye)

Interventions

Aflibercept DRUG

Total 4 times of intravitreal aflibercept injection was performed

Also known as: Eylea

Type 1 polypoidal choroidal vasculopathy; Type 2 polypoidal choroidal vasculopathy

Indocyanine green angiography (intraveonus indocyanine green dye) 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 1 polypoidal choroidal vasculopathy; Type 2 polypoidal choroidal vasculopathy

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• symptomatic typical PCV accompanying branch vascular network involving subfoveal area
• signed informed consent; and
• over 6 months follow-up period after enrollment.

You may not qualify if:

• retinal diseases other than PCV
• extrafoveal PCV not involving subfoveal area
• massive subretinal hemorrhage blocking polypoidal lesion on ICGA
• severe media opacity such as senile cataract
• previous history of intravitreal injection
• previous intraocular surgery history except cataract surgery which was done more than 3 months.

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University College of Medicine

Daegu, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27597740 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Min Sagong
• Organization: Yeungnam University College of Medicine

msagong@ynu.ac.kr

82-53-620-4191

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 18, 2016
• Results First Posted: June 17, 2016

Record last verified: 2016-07

Locations

KR (1)