UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015962 |
|---|---|
| Receipt number | R000018570 |
| Scientific Title | A study of the effectiveness and safety of pars plana vitrecotmy with subretinal oxiglutatione injection for the treatment of refractory macular edema |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2018/12/18 11:40:03 |
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Basic information
Public title
A study of the effectiveness and safety of pars plana vitrecotmy with subretinal oxiglutatione injection for the treatment of refractory macular edema
Acronym
Subretinal oxiglutatione injection for the treatment of macular edema
Scientific Title
A study of the effectiveness and safety of pars plana vitrecotmy with subretinal oxiglutatione injection for the treatment of refractory macular edema
Scientific Title:Acronym
Subretinal oxiglutatione injection for the treatment of macular edema
Region
| Japan |
Condition
Condition
macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effictiveness and safety of pars plana vitrecotmy with subretinal oxiglutatione injection for the treatment of refractory macular edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity improvement at postoperative 6 months
Key secondary outcomes
change of the following parameters at postoperative 6 months from the baseline: (1) macular thickness measured by optical coherence tomography, (2) visual field, (3) electroretinogram
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
| Maneuver |
Interventions/Control_1
Pars plana vitrecotmy with subretinal oxiglutatione injection is performed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with macular edema who are under hospitalization or going to hospital regularly
Key exclusion criteria
(1) the patients who refused the consent for this study
(2) the patient judged to be unsuitable for study participation by doctor in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sentaro Kusuhara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Ophthalmology, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
kusu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sentaro Kusuhara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Ophthalmology, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
Homepage URL
kusu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018570
