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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950741
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ji Eun Lee, Pusan National University Hospital

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

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy Drug: aflibercept Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Study Start Date : September 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

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Arms and Interventions
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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 Name: Eyelea, VEGF Trap-Eye


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950741


Locations
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Korea, Republic of
Busan Paik Hospital
Busanjin-gu, Busan, Korea, Republic of, 614-735
Haeundae Paik Hospital
Haeundae, Busan, Korea, Republic of, 612-030
Gospel Hospital
Seo-gu, Busan, Korea, Republic of, 602-702
Pusan National University Hospital
Seo-gu, Busan, Korea, Republic of, 602-739
Keimyung University Dongsan Medical Center
Jung-gu, Daegu, Korea, Republic of
Kyungpook National University Hospital
Jung-gu, Daegu, Korea, Republic of
Yeungnam University Medical Center
Nam-gu, Daegu, Korea, Republic of, 705-717
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702
Sponsors and Collaborators
Pusan National University Hospital
Bayer
Investigators
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Study Director: Jae Pil Shin, MD, PhD Kyungbuk National University Hospital
More Information
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Publications:

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Responsible Party: Ji Eun Lee, Associate professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01950741    
Other Study ID Numbers: D-1304-013-014
First Posted: September 25, 2013    Key Record Dates
Results First Posted: April 29, 2016
Last Update Posted: April 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Vascular Diseases
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Cardiovascular Diseases