UMIN-CTR Clinical Trial

Public title

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

Acronym

Investigation of aflivercept for PCV with resistance of ranibizumab

Scientific Title

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

Scientific Title:Acronym

Investigation of aflivercept for PCV with resistance of ranibizumab

Region

Japan

Condition

Polypoidal choroidal vasculopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the 52-week efficacy of aflibercept on best-collected visual acuity and polypoidal lesions in patients with ranibizumab-resistant PCV by treat-and-adjusted interval injections of aflibercept.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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)

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

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 interval.
Patients receive the last injection until 50 weeks.
The number of injections and the timing of the last injection varies among patients. (min # of injections: 8, max # of injections: 13, patients will receive the last injection either on the 44th , 48th, or 50th weeks)

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) 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

Key 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.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Yanagi, MD, PhD

Organization

Graduate School of Medicine,
The University of Tokyo

Division name

Department of Ophthalmology

Zip code

Address

7-3-1 Hongo, Bunkyo-Ku, Tokyo

TEL

03-3815-5411

Email

yanagi-tky@umin.org

Name of contact person

1st name
Middle name
Last name	Yasuo Yanagi, MD, PhD

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Ophthalmology

Zip code

Address

7-3-1 Hongo, Bunkyo-Ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

yanagi-tky@umin.org

Institute

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

Institute

Department

Personal name

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

東京大学医学部付属病院（東京都）

Date of disclosure of the study information

2013

Year

12

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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

Terminated

Date of protocol fixation

2013

Year

09

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

04

Day

Last modified on

2016

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014625