UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014436 |
|---|---|
| Receipt number | R000016797 |
| Scientific Title | The clinical study associated with the treatment effects and effectiveness prediction of subretinal neovascularization lesion. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/07/01 00:40:30 |
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Basic information
Public title
The clinical study associated with the treatment effects and effectiveness prediction of subretinal neovascularization lesion.
Acronym
The study of treatment and prognosis for AMD
Scientific Title
The clinical study associated with the treatment effects and effectiveness prediction of subretinal neovascularization lesion.
Scientific Title:Acronym
The study of treatment and prognosis for AMD
Region
| Japan |
Condition
Condition
Age-related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess clinical factors for selecting optionally treatment modalities of AMD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity and central retinal thickness before and after each treatment.
Key secondary outcomes
Disease type and history of ophthalmic treatment and systemic factors.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with age-related macular degeneration.
Key exclusion criteria
Patients who disagreed with this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Yamashita |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
2-2-2 Iidanishi, Yamagata
TEL
023-628-5374
hyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Murakami |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
2-2-2 Iidanishi Yamagata
TEL
023-628-5047
Homepage URL
ikekenkyu@jm.kj.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Sciences Yamagata
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Sciences Yamagata University Faculty of Medicine
Organization
Division
Category of Funding 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
山形大学医学部附属病院(山形県)/Yamagata University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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 | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
We will assess outcomes of treatment about subretinal neovascularization lesion.
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
