Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Phase 4CompletedNCT01950741

Pusan National University Hospital48 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Exudative Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy

Interventions

afliberceptDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Busan Paik Hospital

Busanjin-gu, Busan, South Korea

Haeundae Paik Hospital

Haeundae, Busan, South Korea

Gospel Hospital

Seo-gu, Busan, South Korea

Pusan National University Hospital

Seo-gu, Busan, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: Baseline and 12 months

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.

Time frame: 12 months

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.

Time frame: 12 months

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.

Data from ClinicalTrials.gov

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