UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015286 |
|---|---|
| Receipt number | R000013333 |
| Scientific Title | Clinical study of the Avastin intravitreal injection to thick macula after surgery of epiretinal membrane |
| Date of disclosure of the study information | 2014/09/29 |
| Last modified on | 2016/11/28 19:29:53 |
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Basic information
Public title
Clinical study of the Avastin intravitreal injection to thick macula after surgery of epiretinal membrane
Acronym
The Avastin intravitreal injection to thick macula after surgery of epiretinal membrane
Scientific Title
Clinical study of the Avastin intravitreal injection to thick macula after surgery of epiretinal membrane
Scientific Title:Acronym
The Avastin intravitreal injection to thick macula after surgery of epiretinal membrane
Region
| Japan |
Condition
Condition
Epiretinal Membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the Avastin intravitreal injection for the refractory macula thickness after surgery of the epiretinal membrane.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of disappearance of the exudative retinal detachment and/or retinal edema after the treatment.
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Intravitreal injection of bevasizmab(Avastin) for residual macular edema after epiretinal membrane removal
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 underwent vitrectomy for epiretinal membrane in more than 3 months ago.
The patients with macular edema, and the central retinal thickness is more than 300 micro meters.
Key exclusion criteria
The patients with other associated ocular and macular conditions that compromised visual acuity
Inability to obtain photographs of ocular fundus.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Shiraga |
Organization
Okayama University Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-5-1 Shikata-chou, Kita-ku, Okayama-city Shikata-chou, Kita-ku, Okayama-city
TEL
086-235-7297
fumio327@symphony.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Shiode |
Organization
Okayama University Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-5-1 Shikata-chou, Kita-ku, Okayama-city
TEL
086-235-7297
Homepage URL
shiode2001@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 29 | 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
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2014 | Year | 09 | Month | 29 | Day |
Last modified on
| 2016 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013333
