Overview

This trial is active, not recruiting.

Conditions exudative age-related macular degeneration, polypoidal choroidal vasculopathy
Treatment aflibercept
Phase phase 4
Target VEGF
Sponsor Pusan National University Hospital
Collaborator Bayer
Start date September 2013
End date August 2015
Trial size 48 participants
Trial identifier NCT01950741, D-1304-013-014

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
aflibercept Eyelea, VEGF Trap-Eye
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.

Primary Outcomes

Measure
Visual acuity reservation
time frame: 12 months

Secondary Outcomes

Measure
Visual acuity changes
time frame: 12 months
Visual acuity >20/200
time frame: 12 months
Visual acuity >20/40
time frame: 12 months
ICG angiography
time frame: 12 months
Quality of Life
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Pusan National University Hospital.