Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab

Not Applicable

• Conditions: Polypoidal choroidal vasculopathy

• Registration Number: JPRN-UMIN000012493
• Lead Sponsor: Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

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 (<6 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 8) RPE tear or stage3 full-thickness macular hole in the studied eye. 9) Intraocular surgery (including cataract surgery, vitrectomy and subretinal surgery) in the studied eye within 6months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of improved/maintained visual acuity at week 52 Regression of polyp on indocyanine green angiography (ICGA)

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, regression of polyp on indocyanine green angiography (ICGA)