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

Pusan National University

Status and phase: Completed; Phase 4

Conditions: Exudative Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy

Treatments: Drug: aflibercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01950741

D-1304-013-014

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

aflibercept

Experimental group

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).

Treatment:

Drug: aflibercept