Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pusan National University Hospital
• Collaborator: Bayer
• Treatments: Aflibercept

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

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