UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008976 |
|---|---|
| Receipt number | R000008401 |
| Scientific Title | Clinical trial of intravitreal activated Protein C (Anact C®) for central retinal vein occusion |
| Date of disclosure of the study information | 2012/09/25 |
| Last modified on | 2012/09/25 11:49:16 |
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Basic information
Public title
Clinical trial of intravitreal activated Protein C (Anact C®) for central retinal vein occusion
Acronym
Intravitreal APC for CRVO
Scientific Title
Clinical trial of intravitreal activated Protein C (Anact C®) for central retinal vein occusion
Scientific Title:Acronym
Intravitreal APC for CRVO
Region
| Japan |
Condition
Condition
Central retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of intravitreal activated Protein C (Anact C) for central retinal vein occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Visual acuity, intraocular pressure, slit lamp and fundus examination, and optical coherence tomography before and at 2 days, 2 weeks, 1, 2, 3, 6, 9 and 12 months after injection. Recording any adverse effects.
Key secondary outcomes
Fluorescein angiography for evaluating retinal circulation at 6 and 12 months after injection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Central retinal vein occlusion
One month or less after the onset
Visual acuity between 20/2000 and 20/50
Central foveal thickness of 350um or more
Key exclusion criteria
Cases with other retinal disorder such as diabetic retinopathy or macular diseases.
Cases with other serious eye diseases such as glaucoma.
Cases with previous treatments such as steroid therapy, anti-VEGF therapy or laser photocoagulation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Kamei |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, #E7, Suita, Osaka
TEL
06-6879-3456
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
06-6879-3456
Homepage URL
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2012 | Year | 09 | Month | 25 | Day |
Last modified on
| 2012 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008401
