Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Phase 4

Completed

Conditions: Exudative Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy

Interventions: Drug: aflibercept

Registration Number: NCT01950741

Lead Sponsor: Pusan National University Hospital

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aflibercept	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Lose Visual Acuity Less Than 15 Letters	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

Name	Time	Method
Change in Visual Acuity From Baseline to 12 Months	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.
Percentage of Patients With Visual Acuity >=20/200	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.
Percentage of Patients With Visual Acuity >=20/40	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.
VFQ (Visual Function Questionaire)-25 Score	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.
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography	12 months	ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.

Trial Locations

Locations (8): Yeungnam University Medical Center
🇰🇷
Nam-gu, Daegu, Korea, Republic of
Pusan National University Hospital
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Seo-gu, Busan, Korea, Republic of
Haeundae Paik Hospital
🇰🇷
Haeundae, Busan, Korea, Republic of
Busan Paik Hospital
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Busanjin-gu, Busan, Korea, Republic of
Gospel Hospital
🇰🇷
Seo-gu, Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
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Jung-gu, Daegu, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷
Jinju, Gyeongsangnam-do, Korea, Republic of
Kyungpook National University Hospital
🇰🇷
Jung-gu, Daegu, Korea, Republic of