UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011273
Receipt number R000013212
Scientific Title Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Date of disclosure of the study information 2013/07/25
Last modified on 2018/07/30 08:35:56

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Basic information

Public title

Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)

Acronym

Effect of aflibercept in wAMD with PED

Scientific Title

Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)

Scientific Title:Acronym

Effect of aflibercept in wAMD with PED

Region

Japan


Condition

Condition

exudative age related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of aflibercept on visual acuity and retinal morphology in AMD with PED

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Ratio of patients with improved/maintained BCVA at month 12
2) Ratio of patients with PED regression

Key secondary outcomes

Change of BCVA, PED, central macular thickness, polyp lesion, etc.


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

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) Willingness to provide written informed consent
2) wAMD with CNV on FA, ICGA, OCT
3) PED (>1 disc diameter) on OCT
4) Treatment na&iuml;ve
5) BCVA > 0.1 (decimal score)

Key exclusion criteria

1) Drusenoid PED
2) Avascular PED
3) GLD of the total lesion area > 12
4) Presence of RPE tears or macular hole
5) Subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
5) History of Triamcinolone (< 6 months), dexamethasone (< 30 days), intraocular surgery (< 6 months)
6) Vitrectomy, submacular surgery, etc.
7) Active intraocular inflammation
8) Hypersensitivity or allergy to fluorescein, indocyanine green, etc.
9) Pregnancy, lactating woman

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kanji Takahashi

Organization

Kansai Medical University

Division name

Department of Ophthalmology

Zip code


Address

Shinmachi 2-5-1, Hirakata

TEL

072-804-0101

Email

nagaiy@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshimi Nagai

Organization

Kansai Medical University

Division name

Department of Ophthalmology

Zip code


Address

Shinmachi 2-5-1, Hirakata

TEL

072-804-0101

Homepage URL


Email

nagaiy@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

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

関西医科大学附属病院、関西医科大学附属滝井病院、大阪大学医学部附属病院、住友病院


Other administrative information

Date of disclosure of the study information

2013 Year 07 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

Terminated

Date of protocol fixation

2013 Year 07 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2015 Year 06 Month 30 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 07 Month 25 Day

Last modified on

2018 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name