NCT01871376

Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gregg T. Kokame, MD · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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®.

Conditions

• Polypoidal Choroidal Vasculopathy

Interventions

Type	Name	Description
DRUG	Intravitreal aflibercept injection 2.0mg	Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-06-06
• Last updated: 2016-11-23

Locations

1 site across 1 country: United States