UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014946
Receipt number R000015409
Scientific Title Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Date of disclosure of the study information 2016/07/07
Last modified on 2017/03/25 22:09:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration

Acronym

Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration

Scientific Title

Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration

Scientific Title:Acronym

Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration

Region

Japan


Condition

Condition

Wet age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the visual outcome of treat and extend regimen(TAE) in managing wet age-related macular degeneration with intravitreal aflibercept.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of eyes at week 52 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravitreal aflibercept with traet and extend regimen

Interventions/Control_2

Intravitreal aflibercept every 8 weeks

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with new-onset, active, subfoveal, choroidal neovascularization lesions (or juxtafoveal with leakage affecting the fovea) secondary to age-related macular degeneration

Key exclusion criteria

Presence of other causes of CNV, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
Active intraocular inflammation in the study eye.
Active ocular or periocular infection in study eye.
Uncontrolled glaucoma in the study eye.
Prior treatment with anti VEGF therapy in the study eye.
History of myocardial infarction or stroke in the past 3 months.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenobu Tanihara

Organization

Faculty of life sciences, Kumamoto university

Division name

Department of ophthalmology

Zip code


Address

1-1-1,honjyo,chuo-ku,kumamoto,kumamoto,japan

TEL

096-344-2111

Email

ganka@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuya Inomata

Organization

Faculty of life sciences, Kumamoto university

Division name

Department of ophthalmology

Zip code


Address

1-1-1,honjyo,chuo-ku,kumamoto,kumamo

TEL

096-344-2111

Homepage URL


Email

inoyas@kxb.biglobe.ne.jp


Sponsor or person

Institute

Faculty of life sciences, Kumamoto university

Institute

Department

Personal name



Funding Source

Organization

Faculty of life sciences, Kumamoto university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

熊本大学医学部附属病院(熊本県)、出田眼科医院(熊本県)


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 07 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

Completed

Date of protocol fixation

2014 Year 07 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 10 Month 31 Day

Date analysis concluded

2016 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 25 Day

Last modified on

2017 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name