UMIN-CTR Clinical Trial

Public title

Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Acronym

Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Scientific Title

Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Scientific Title:Acronym

Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy

Region

Japan

Condition

polypoidal choroidal vasculopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the best corrected visual acuity 12 months after intravitreal aflibercept treatment, which was performed with 3 monthly injections followed by 4 bimonthly ones.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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 following induction phase.
4) Injection procedure or follow-up regimen is based on guideline in each affiliation.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Akira Arakawa

Organization

Yokohama City University Medical Center

Division name

Ophthalmology

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

a_ara@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Akira Arakawa

Organization

Yokohama City University Medical Center

Division name

Ophthalmology

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

a_ara@yokohama-cu.ac.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

Bayer HealthCare

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属市民総合医療センター（神奈川県）

Date of disclosure of the study information

2013

Year

04

Month

12

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26710307

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

02

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

15

Day

Last follow-up date

2014

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

10

Day

Last modified on

2016

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012225