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Completed

NCT Number: NCT01950741

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

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

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Key information

Conditions

Exudative Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Polypoidal Choroidal Vasculopathy Uveal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Busan Paik Hospital, Busanjin-gu, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.

Other names: Eyelea, VEGF Trap-Eye

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: VAULT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2013
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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