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Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV)

Not Applicable
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
Proportion of improved/maintained visual acuity at month 12
Secondary Outcome Measures
NameTimeMethod
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)
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