UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030311
Receipt number R000034617
Scientific Title Clinical study in new protocol of anti-VEGF agents for macular edema with retinal vein occlusion and in relation between the protocol and cytokines
Date of disclosure of the study information 2017/12/09
Last modified on 2023/12/13 09:13:34

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Basic information

Public title

Clinical study in new protocol of anti-VEGF agents for macular edema with retinal vein occlusion and in relation between the protocol and cytokines

Acronym

Relationship between new protocol of anti-VEGF agents and cytokines for RVO

Scientific Title

Clinical study in new protocol of anti-VEGF agents for macular edema with retinal vein occlusion and in relation between the protocol and cytokines

Scientific Title:Acronym

Relationship between new protocol of anti-VEGF agents and cytokines for RVO

Region

Japan


Condition

Condition

Retinal Vein Occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate new protocol of anti-VEGF agents for macular edema with retinal vein occlusion.

Basic objectives2

Others

Basic objectives -Others

To evaluate the relation between the protocol and cytokines for macular edema with retinal vein occlusion.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity and central macular thickness every month

Key secondary outcomes



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

injection of anti-VEGF agents 0.05 ml (first time and at the inactivate interval)

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1)visual acuity <0.9
2)central macular thickness > 300

Key exclusion criteria

1)patients who were performed operation
2)patients with active uveitis
3)patients with rubeosis
4)patients with uncontrolled glaucoma
5)patients with severe diabetic retinopathy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Shimura

Organization

Hachioji Medical Center, Tokyo Medical University

Division name

Department of Ophthalmology

Zip code

193-0998

Address

1163, Tatemachi, Hachioji, Tokyo 193-0998

TEL

042-665-5611

Email

masahiko@v101.vaio.ne.jp


Public contact

Name of contact person

1st name Hidetaka
Middle name
Last name Noma

Organization

Hachioji Medical Center, Tokyo Medical University

Division name

Department of Ophthalmology

Zip code

193-0998

Address

1163, Tatemachi, Hachioji, Tokyo 193-0998

TEL

042-665-5611

Homepage URL


Email

noma-hide@umin.ac.jp


Sponsor or person

Institute

Tokyo medical university

Institute

Department

Personal name



Funding Source

Organization

None.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hachioji Medical Center, Tokyo Medical University

Address

1163, Tatemachi, Hachioji, Tokyo 193-0998

Tel

042-665-5611

Email

masahiko@v101.vaio.ne.jp


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

2017 Year 12 Month 09 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

2017 Year 04 Month 12 Day

Date of IRB

2017 Year 04 Month 12 Day

Anticipated trial start date

2017 Year 06 Month 08 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 08 Day

Last modified on

2023 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name