Comparison of the Short-term Outcomes of Intravitreal Aflibercept Injection Between Two Subtypes of Polypoidal Choroidal Vasculopathy Using Indocyanine Green Angiography

Polypoidal Choroidal Vasculopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597855
• Other study ID #: YUMC2015-08-036
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: November 3, 2015
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2015
• Source: Yeungnam University College of Medicine
• Contact: Min Sagong
• Phone: 82-53-620-4191
• Email: msagong[@]ynu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Aflibercept
At initial visit, indocyanine green angiography was performed. After diagnosis of PCV, monthly intravitreal Aflibercept injection was done. (3 times) After 1monts of 3rd Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.
• Indocyanine green angiography (intraveonus indocyanine green dye)
At initial visit, indocyanine green angiography was performed. After diagnosis of PCV, monthly intravitreal Aflibercept injection was done. (3 times) After 1monts of 3rd Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University College of Medicine	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regression rate of polyp on indocyanine green angiography		3 months	No
Primary	Changes of best corrected visual acuity		3 months and 6 months	No
Secondary	Change of central retinal thickness, largest polyp diameter, largest pigment epithelium detachment height, central choroidal thickness	all these parameters were evaluated manually on optical coherence tomography program (Heidelberg Engineering , Heiderberg, Germany) by one ophthalmologist. (Measurement units : micrometer)	3 months and 6 months	No