UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012549
Receipt number R000014677
Scientific Title Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema
Date of disclosure of the study information 2014/03/01
Last modified on 2014/04/21 17:50:34

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Basic information

Public title

Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema

Acronym

Combination treatment of intravitreal Ranibizumab and photocoagulation in patients with diabetic macula edema

Scientific Title

Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema

Scientific Title:Acronym

Combination treatment of intravitreal Ranibizumab and photocoagulation in patients with diabetic macula edema

Region

Japan


Condition

Condition

diabetic macula edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the mean gain in BCVA and the number of intravitreal ranibizumab injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity improvement, central macula thickness, number of intravitreal renibizumab injections

Key secondary outcomes

intra ocular pressure, plasma levels of vascular endothelial growth factor(VEGF), aqueous concentrations of various cytokines, blood pressure


Base

Study type


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intravitreal ranibizumab injections
retinal photocoagulation

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)stable medication for the management of diabetes within 3 months
2)visual impairment due to focal or diffuse DME
3)decreased vision due to DME and not other causes

Key exclusion criteria

1)concomitant conditions in the study eye that could prevent the improvement in VA on the study
2)active intraocular inflammation or infection in either eye
3)uncontrolled glaucoma in either eye
4)treatment with antiangiogenic drugs in the study eye within 3 months before randomization
5)history of stroke and systolic blood pressure>160mmHg or diastolic BP>100mmHg,untreated hypertension, or change in antihypertensive treatment within 3 months preceding baseline.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Murata Toshinori

Organization

Shinshu university school of medicine

Division name

Department of Ophthalmology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

+81-263-37-2664

Email

murata@sshinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takao Hirano

Organization

Shinshu university school of medicine

Division name

Department of Ophthalmology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

+81-263-37-2664

Homepage URL


Email

takaoh@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu university school of medicine
Department of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Novartis Pharma K.K.

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

信州大学附属病院(長野県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 01 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 03 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 01 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

2013 Year 12 Month 11 Day

Last modified on

2014 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name