Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy (VAULT)

March 29, 2016 updated by: Ji Eun Lee, Pusan National University Hospital

An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

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

  • Korea, Republic of
    • Busan
      • Busanjin-gu, Busan, Korea, Republic of, 614-735
        • Busan Paik Hospital
      • Haeundae, Busan, Korea, Republic of, 612-030
        • Haeundae Paik Hospital
      • Seo-gu, Busan, Korea, Republic of, 602-702
        • Gospel Hospital
      • Seo-gu, Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
    • Daegu
      • Jung-gu, Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Jung-gu, Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Nam-gu, Daegu, Korea, Republic of, 705-717
        • Yeungnam University Medical Center
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Submacular PCV diagnosed using ICG angiography with no previous treatment (branching vascular network with or without polypoidal dilation in ICG angiography)

  • Presence of signs of recent activity of PCV

    1. Visual acuity between 20/40 and 20/320
    2. Active leakage in fluorescein angiography
    3. Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial

Exclusion Criteria:

  1. Extramacular PCV
  2. Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion.
  3. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)
  4. Previous treatment of photodynamic therapy
  5. Previous ocular surgery except cataract surgery before 3 or more months
  6. Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.)
  7. Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc)
  8. Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc)
  9. Patients who cannot understand or conform to the study protocol.
  10. Patients who refuse to agree to the informed consent.

  11. Patients with contraindication to aflibercept

    • Ocular or periocular infection
    • Active severe intraocular inflammation
    • Known hypersensitivity to aflibercept or to any of the excipients

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aflibercept
Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
Drug: aflibercept
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Other Names:
  • Eyelea, VEGF Trap-Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Lose Visual Acuity Less Than 15 Letters
Time Frame: 12 months
Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity From Baseline to 12 Months
Time Frame: Baseline and 12 months
Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.
Baseline and 12 months
Percentage of Patients With Visual Acuity >=20/200
Time Frame: 12 months
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.
12 months
Percentage of Patients With Visual Acuity >=20/40
Time Frame: 12 months
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.
12 months
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography
Time Frame: 12 months
ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.
12 months
VFQ (Visual Function Questionaire)-25 Score
Time Frame: 12 months
Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.
12 months

Collaborators and Investigators

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

Sponsor

Pusan National University Hospital

Collaborators

Bayer

Investigators

  • Study Director: Jae Pil Shin, MD, PhD, Kyungbuk National University Hospital

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, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-1304-013-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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