Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV)
- Conditions
- Polypoidal Choroidal Vasculopathy
- Registration Number
- JPRN-UMIN000011091
- Lead Sponsor
- Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas 2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area) 3) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months) 4) Active intraocular inflammation 5) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products 6) pregnant women and nursing mothers 7) Patient who the doctor in charge judges are ineligible for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of improved/maintained visual acuity at month 12
- Secondary Outcome Measures
Name Time Method Change of BCVA (best-collected visual acuity), central macular thickness and subretinal fluid on OCT (optical coherence tomography), disease area on fluorescent angiography (FA), regression of polyp on indocyanine green angiography (ICGA)