Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Rajavithi Hospital1 site in 1 country50 target enrollmentDecember 30, 2016

Overview

Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.

Registry

clinicaltrials.gov

Start Date

December 30, 2016

End Date

December 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Male or Female \>/= 18 years
•Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
•BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters

•Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])
•Active ocular inflammation or infection (ocular or periocular)
•Uncontrolled intraocular hypertension or glaucoma (IOP\> 30 mmPIg) despite treatment with anti-glaucoma medication
•Predominantly-scarred PCV lesions
•Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
•Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
•Prior treatment with any anti-VEGF compound or any investigational treatment
•Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days