UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012126
Receipt number R000014181
Scientific Title Study of intravitreal aflibercept for exudative age-related macular degeneration
Date of disclosure of the study information 2013/10/25
Last modified on 2016/04/25 13:33:53

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Basic information

Public title

Study of intravitreal aflibercept for exudative age-related macular degeneration

Acronym

Intravitreal aflibercept for AMD

Scientific Title

Study of intravitreal aflibercept for exudative age-related macular degeneration

Scientific Title:Acronym

Intravitreal aflibercept for AMD

Region

Japan


Condition

Condition

Age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of aflibercept with 3 injections for loading phase and bimonthly injections in patients with wAMD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of maintained visual acuity at month 12 (defined as loss of less than 3 lines)

Key secondary outcomes

Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, contrast sensitivity and mean deviation of humphrey visual field


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eylea (aflibercept)

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



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) BCVA: 0.1-1.0
2) AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatient

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 anti-VEGF drug, photodynamic therapy
4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5) Active intraocular inflammation
6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7) Patient who the doctor in charge judges are ineligible for the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Sakai

Organization

Jikei University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

3-25-8 nishishinbashi minatoku tokyo 105-8461 japan

TEL

+81-3-3433-1111

Email

tstmski@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Sakai

Organization

Jikei University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

3-25-8 nishishinbashi minatoku tokyo 105-8461 japan

TEL

+81-3-3433-1111

Homepage URL


Email

tstmski@jikei.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2013 Year 07 Month 08 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 25 Day

Last follow-up date

2015 Year 10 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 25 Day

Last modified on

2016 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014181


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name