UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023590
Receipt number R000026913
Scientific Title The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).
Date of disclosure of the study information 2016/08/15
Last modified on 2016/08/10 18:53:33

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Basic information

Public title

The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).

Acronym

Focal macular ERG with wAMD sfter IVA.

Scientific Title

The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).

Scientific Title:Acronym

Focal macular ERG with wAMD sfter IVA.

Region

Japan


Condition

Condition

Age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Primary study objective is to investigate effect of aflibercept on visual acuity and focal macular ERG of japanese wAMD patients at 12M.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

The change of the amplitude of the focal macular ERG at the 12 month from baseline.

Key secondary outcomes

1. Change of BCVA at the 12 month.
2. Change of the amplitude of the focal macular ERG at the 3,6 and 12 month.
3. Change of the retinal thickness evaluated by SD-OCT at the 12 month.
4. Correlation between the focal macular ERG amplitude and BCVA.
5. Correlation between the focal macular ERG amplitude and retinal thickness.


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) naive AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatients

Key exclusion criteria

1) Patients with any previous history of treatment of other retinal diseases with pharmacologic agents including verteporfin photodynamic therapy, aflibercept, ranibizumab, bevacizumab or steroids.
2) Clinically significant drug allergy.
3) History of vitrectomy or glaucoma surgery.
4) Presence of RPE tears, angoid streaks or pathologic myopia.
5) Concomitant conditions/diseases including uncontrolled glaucoma and intraocular inflammation
6) Patients who the doctor in charge judges are ineligible for the study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeki Machida

Organization

Dokkyo Medical University, Koshigaya Hospital

Division name

Department of Ophthalmology

Zip code


Address

2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan

TEL

048-965-1111

Email

machidas@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeki Machida

Organization

Dokkyo Medical University, Koshigaya Hospital

Division name

Department of Ophthalmology

Zip code


Address

2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan

TEL

048-965-1111

Homepage URL


Email

machidas@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University, Koshigaya Hospital
Department of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 15 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

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 20 Day

Last follow-up date

2018 Year 04 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

2016 Year 08 Month 10 Day

Last modified on

2016 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name