UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012549
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Shinshu university school of medicine
Department of Ophthalmology
Institute
Department

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
URL(English) https://upload.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


Contact us.