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
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
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
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
