Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation — EPIC  

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title: Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

Status Completed

Clinical Trial Summary

To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV

Clinical Trial Description

This is an open-label, randomized, one-year, multiple-dose study of 2mg aflibercept in patients with PCV.

The study consists of the baseline visit on day 0 and a mandatory clinic visit every 30 days to assess efficacy and safety. All patients will receive three monthly injections of 2mg intravitreal aflibercept injection followed by treatment every 60 days through 720 days (24 months). Patients can be treated every 30 days if needed.

The fellow eye may be treated with intravitreal aflibercept injection per the investigator's discretion at any point during the study if evidence of disease activity are met: exudation or hemorrhage secondary to polypoidal choroidal vasculopathy or exudative AMD. The fellow eye will not be considered the study eye. If treatment with aflibercept is to be given in the fellow eye, the injections are to be administered according to the Food and Drug Administration (FDA) approved label for EYLEA®. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

• NCT number: NCT01871376
• Study type: Interventional
• Source: Hawaii Pacific Health
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Completion date: September 2016