Phase 4 N=48 Treatment

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Exudative Age-related Macular Degeneration · Polypoidal Choroidal Vasculopathy

Bottom Line

View on ClinicalTrials.gov: NCT01950741 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Apr 2016

Primary outcome: Primary: Percentage of Patients Lose Visual Acuity Less Than 15 Letters — 87.5 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: aflibercept (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pusan National University Hospital
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Lose Visual Acuity Less Than 15 Letters	87.5	—
SECONDARY Change in Visual Acuity From Baseline to 12 Months	9	—
SECONDARY Percentage of Patients With Visual Acuity >=20/200	95.0	—
SECONDARY Percentage of Patients With Visual Acuity >=20/40	52.5	—
SECONDARY Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography	66.7	—
SECONDARY VFQ (Visual Function Questionaire)-25 Score	72.6	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01950741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.