Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Without Active Polyp Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072408
• Other study ID #: 2013-10-044-002
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: November 2, 2017

Study information

• Verified date: February 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• polypoidal choroidal vasculopathy without active polyp

• decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

Exclusion Criteria:

• polypoidal choroidal vasculopathy with active polyp

• previous photodynamic therapy more than three times

• anti-VEGF injection within one month

• photodynamic therapy or intraocular steroid treatment within three months

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy Without Active Polyp
• Vascular Diseases

Intervention

Drug:
• aflibercept
Three monthly intravitreal aflibercept (2mg) injections Five bimonthly intravitreal aflibercept (2mg) injections Rescue treatment: Verteporfin photodynamic therapy Loss of five ETDRS letters or one Snellen line of vision from baseline Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection Presence of active polyp on indocyanine green angiography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do
Korea, Republic of	Konyang University Kim's Eye Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Samsung Medical Center	Bayer, Kim's Eye Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of best-corrected visual acuity (ETDRS letters)		1 year
Secondary	presence of subretinal hemorrhage	Total number of months when subretinal hemorrhage are detected on fundus photographs.	during 1 year
Secondary	presence of fluid in macula evidenced by optical coherence tomography	Total number of months when fluid in macula are detected on optical coherence tomography	during 1 year
Secondary	change of indocyanine green angiography	Change of indocyanine green angiography will include followings; New appearance of polypoidal structure; Any change in size of the greatest linear dimension of lesion; Any change in size and activity of branching vascular network	during 1 year
Secondary	Number of eyes which need rescue treatment (photodynamic therapy)	In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.	during 1 year
Secondary	safety outcomes	frequency and severity of ocular adverse event	one year