NCT02072408

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
Last Updated

September 5, 2018

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

February 10, 2014

Last Update Submit

September 2, 2018

Conditions

Polypoidal Choroidal Vasculopathy Without Active Polyp

Outcome Measures

Primary Outcomes (1)

  • Change of best-corrected visual acuity (ETDRS letters)

    1 year

Secondary Outcomes (5)

  • presence of subretinal hemorrhage

    during 1 year

  • presence of fluid in macula evidenced by optical coherence tomography

    during 1 year

  • change of indocyanine green angiography

    during 1 year

  • Number of eyes which need rescue treatment (photodynamic therapy)

    during 1 year

  • safety outcomes

    one year

Study Arms (1)

polypoidal choroidal vasculopathy without polyp

EXPERIMENTAL
Drug: aflibercept

Interventions

afliberceptDRUG

1. Three monthly intravitreal aflibercept (2mg) injections 2. Five bimonthly intravitreal aflibercept (2mg) injections 3. 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

polypoidal choroidal vasculopathy without polyp

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • polypoidal choroidal vasculopathy without active polyp
  • decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Location

Konyang University Kim's Eye Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 26, 2014

Study Start

February 1, 2014

Primary Completion

November 2, 2017

Study Completion

November 2, 2017

Last Updated

September 5, 2018

Record last verified: 2014-02

Locations

KR(3)