UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016308
Receipt number R000018929
Scientific Title Study of the effect of direct/grid laser photocoagulation and intravitreal ranibizumab in patients with macular edema following retinal vein occlusion
Date of disclosure of the study information 2015/01/25
Last modified on 2022/01/28 09:41:45

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Basic information

Public title

Study of the effect of direct/grid laser photocoagulation and intravitreal ranibizumab in patients with macular edema following retinal vein occlusion

Acronym

Combination therapy of direct/grid laser photocoagulation and intravitreal Ranibizumab in patients with macular edema following retinal vein occlusion

Scientific Title

Study of the effect of direct/grid laser photocoagulation and intravitreal ranibizumab in patients with macular edema following retinal vein occlusion

Scientific Title:Acronym

Combination therapy of direct/grid laser photocoagulation and intravitreal Ranibizumab in patients with macular edema following retinal vein occlusion

Region

Japan


Condition

Condition

retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the efficacy of combination therapy of laser photocoagulation and intravitreal ranibizumab for the patients with macular edema following retinal vein occlusion and investigate the background factors in these patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity, central subfield macular thickness, number of intravitreal ranibizumab injections

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients with macular edema following retinal vein occlusion

Key exclusion criteria

Prior ocular treatment within 3 months before initial intravitreal ranibizumab
History or presence of other ocular deseases causing vision deterioration

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Iesato

Organization

Shinshu university school of medicine

Division name

Department of Ophthalmology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

+81-263-37-2664

Email

iesato@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Iesato

Organization

Shinshu university school of medicine

Division name

Department of Ophthalmology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

+81-263-37-2664

Homepage URL


Email

iesato@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine, Department of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Shinshu 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

Shinshu University

Address

3-1-1 Asahi, Matsumoto

Tel

0263-37-2664

Email

iesato@shinshu-u.ac.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

2015 Year 01 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

Open public recruiting

Date of protocol fixation

2014 Year 10 Month 31 Day

Date of IRB

2014 Year 12 Month 02 Day

Anticipated trial start date

2014 Year 12 Month 03 Day

Last follow-up date

2022 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective
Patient background factors (age, sex, complications, past medical history, duration from symptom to initial IVR, drinking , smoking history , use drugs , blood pressure , visual acuity , intraocular pressure , optical coherence tomography , fluorescein fundus angiography , pupil light )


Management information

Registered date

2015 Year 01 Month 23 Day

Last modified on

2022 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name