Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

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

Detailed Description
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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.

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

Conditions
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Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: aflibercept


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aflibercept<br>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<br>* Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.<br>* Other names: Eyelea, VEGF Trap-Eye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 12 months | 
| 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. | 12 months |