UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014110
Receipt number R000016425
Scientific Title Effect of anti-vascular endothelial growth factor (VEGF) drugs in chronic central serous chorioretinopathy (CSC)
Date of disclosure of the study information 2014/06/01
Last modified on 2018/12/01 12:58:37

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Basic information

Public title

Effect of anti-vascular endothelial growth factor (VEGF) drugs in chronic central serous chorioretinopathy (CSC)

Acronym

Effect of anti-VEGF drugs in chronic CSC

Scientific Title

Effect of anti-vascular endothelial growth factor (VEGF) drugs in chronic central serous chorioretinopathy (CSC)

Scientific Title:Acronym

Effect of anti-VEGF drugs in chronic CSC

Region

Japan


Condition

Condition

chronic central serous chorioretinopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of anti-VEGF drugs on visual acuity and retinal morphology in chronic CSC

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Ratio of patients with improved/maintained best-corrected visual acuity (BCVA) at month 1,3,6,12
2) Ratio of patients with improved central retinal thickness (CRT) at month 1,3,6,12

Key secondary outcomes

Change of BCVA, CRT 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

ranibizumab
pegaputanib
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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Willingness to provide written informed consent
2) Chronic CSC on fluorescein angiography (FA), indocyanine green angiography (IA), optical coherence tomography (OCT)

Key exclusion criteria

none

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuyoshi Otsuji

Organization

Kansai medical university takii hospital

Division name

Department of Ophthalmology

Zip code


Address

10-15 Fumizono-cho Moriguchi, Osaka

TEL

06-6992-1001

Email

otsuji@takii.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Otsuji

Organization

Kansai medical university takii hospital

Division name

Department of Ophthalmology

Zip code


Address

10-15 Fumizono-cho Moriguchi, Osaka

TEL

06-6992-1001

Homepage URL


Email

otsuji@takii.kmu.ac.jp


Sponsor or person

Institute

Kansai medical university takii hospital

Institute

Department

Personal name



Funding Source

Organization

none

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



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 05 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 29 Day

Last modified on

2018 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name