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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012493
Enrollment
30
Registered
2013-12-04
Start date
2013-12-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypoidal choroidal vasculopathy

Interventions

As a loading dose, the patient receives three intravitreal aflibercept injections every 4 weeks. In the maintenance phase, the patient receives aflibercept injection at every 4-, 6- or 8- week interv

Sponsors

Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) age above 50 3) Subfoveal CNV secondary to AMD on FA,IA,OCT 4) PCV on fundus photography and ICGA 5) ranibizumab-resistant Polypoidal choroidal vasculopathy (PCV) 6) BCVA>0.1 7) Treatment-naïve PCV

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Proportion of improved/maintained visual acuity at week 52 Regression of polyp on indocyanine green angiography (ICGA)—

Secondary

MeasureTime frame
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)—

Countries

Japan

Contacts

Public ContactYasuo Yanagi, MD, PhD

Graduate School of Medicine, The University of Tokyo Department of Ophthalmology

yanagi-tky@umin.org03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026