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Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy - Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010461
Enrollment
30
Registered
2013-04-12
Start date
2013-04-15
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

1) Study period start at the day of the first injection of aflibercept. 2) Aflibercept is injected 3 monthly as an induction phase. 3) Aflibercept is injected 4 bimonthly as a maintenance phase foll

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with informed consent 2) Patients with both sexes whose age are 50 or over 3) Patients with exudative age-related macular degeneration 4) Patients who is diagnosed as PCV on fundus photo or ICGA 5) Patients without previous treatment for PCV 6) Dicimal visual acuity of the study eye is between 0.1 and 0.7

Exclusion criteria

Exclusion criteria: 1) Lesion size >=12 disc area (1 disc rea is 30.5mm2). 'Lesion' includes hemorrhage, scar, and CNV. 2) Area of subretinal hemorrage in study eye>=50% of total lesion area 3) Area of scar or fibrosis in study eye>=50% of total lesion area 4) RPE tear in study eye 5) Stage 3 or 4 macular hole in study eye 6) Administration of triamcinolone to study eye within 6 months prior to this study 7) Administration of dexamethasone to study eye within 30 days prior to this study 8) Intraocular surgery to study eye within 6 months prior to this study 9) Any history of vitrectomy in study eye 10) Any inflammation or infection in intra-or extra-ocular tissue in either eye 11) History of uveitis in either eye 12) Allergy to fluorescein, indocyanine or iodine 13) pregnant women and nursing mothers 14) Patients who were judged by docters to be inappropriate for this study

Design outcomes

Primary

MeasureTime frame
Ratio of patients who achieved less than 15 letters loss in ETDRS chart

Secondary

MeasureTime frame
Change of visual acuity in ETDRS chart between baseline and 6 or 12 months after treatment Ratio of polyp regression on ICGA at 6 or 12 months after treatment Ratio of abnormal vascular network regression on ICGA at 6 or 12 months after treatment Change of foveal thickness on OCT between baseline and 6 or 12 months after treatment Change of exudative lesions between baseline and 6 or 12 months after treatment

Countries

Japan

Contacts

Public ContactAkira Arakawa

Yokohama City University Medical Center Ophthalmology

a_ara@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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