search
Back to results

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

Primary Purpose

Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aflibercept
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Busan Paik Hospital
  • Haeundae Paik Hospital
  • Gospel Hospital
  • Pusan National University Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Yeungnam University Medical Center
  • Gyeongsang National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aflibercept

Arm Description

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).

Outcomes

Primary Outcome Measures

Percentage of Patients Lose Visual Acuity Less Than 15 Letters
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.

Secondary Outcome Measures

Change in Visual Acuity From Baseline to 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.
Percentage of Patients With Visual Acuity >=20/200
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.
Percentage of Patients With Visual Acuity >=20/40
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.
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography
ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.
VFQ (Visual Function Questionaire)-25 Score
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.

Full Information

First Posted
September 23, 2013
Last Updated
March 29, 2016
Sponsor
Pusan National University Hospital
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01950741
Brief Title
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Acronym
VAULT
Official Title
An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aflibercept
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
Eyelea, VEGF Trap-Eye
Intervention Description
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Primary Outcome Measure Information:
Title
Percentage of Patients Lose Visual Acuity Less Than 15 Letters
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Visual Acuity From Baseline to 12 Months
Description
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.
Time Frame
Baseline and 12 months
Title
Percentage of Patients With Visual Acuity >=20/200
Description
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.
Time Frame
12 months
Title
Percentage of Patients With Visual Acuity >=20/40
Description
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.
Time Frame
12 months
Title
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography
Description
ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.
Time Frame
12 months
Title
VFQ (Visual Function Questionaire)-25 Score
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Visual acuity between 20/40 and 20/320 Active leakage in fluorescein angiography Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial Exclusion Criteria: Extramacular PCV Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents) Previous treatment of photodynamic therapy Previous ocular surgery except cataract surgery before 3 or more months Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.) Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc) Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc) Patients who cannot understand or conform to the study protocol. Patients who refuse to agree to the informed consent. Patients with contraindication to aflibercept Ocular or periocular infection Active severe intraocular inflammation Known hypersensitivity to aflibercept or to any of the excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Pil Shin, MD, PhD
Organizational Affiliation
Kyungbuk National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Busan Paik Hospital
City
Busanjin-gu
State/Province
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Haeundae Paik Hospital
City
Haeundae
State/Province
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
Facility Name
Gospel Hospital
City
Seo-gu
State/Province
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Seo-gu
State/Province
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Jung-gu
State/Province
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Jung-gu
State/Province
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Nam-gu
State/Province
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju
State/Province
Gyeongsangnam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17021319
Citation
Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.
Results Reference
background
PubMed Identifier
17021318
Citation
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
Results Reference
background
PubMed Identifier
23084240
Citation
Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. Erratum In: Ophthalmology. 2013 Jan;120(1):209-10.
Results Reference
background
PubMed Identifier
20719300
Citation
Stangos AN, Gandhi JS, Nair-Sahni J, Heimann H, Pournaras CJ, Harding SP. Polypoidal choroidal vasculopathy masquerading as neovascular age-related macular degeneration refractory to ranibizumab. Am J Ophthalmol. 2010 Nov;150(5):666-73. doi: 10.1016/j.ajo.2010.05.035. Epub 2010 Aug 16.
Results Reference
background
PubMed Identifier
22426346
Citation
Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.
Results Reference
background

Learn more about this trial

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

We'll reach out to this number within 24 hrs