UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038050 |
|---|---|
| Receipt number | R000043372 |
| Scientific Title | Five-Year Follow-Up of Fundus Autofluorescence and Retinal Sensitivity in the Fellow Eye in Age-Related Macular Degeneration in Japan |
| Date of disclosure of the study information | 2019/12/22 |
| Last modified on | 2019/09/19 09:44:22 |
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Basic information
Public title
Retinal Sensitivity Study in the Fellow Eye in Age-Related Macular Degeneration in Japan
Acronym
Study in the Fellow Eye in Age-Related Macular Degeneration in Japan
Scientific Title
Five-Year Follow-Up of Fundus Autofluorescence and Retinal Sensitivity in the Fellow Eye in Age-Related Macular Degeneration in Japan
Scientific Title:Acronym
The Fellow Eye in Age-Related Macular Degeneration in Japan
Region
| Japan |
Condition
Condition
Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess abnormal fundus autofluorescence (FAF) and retinal sensitivity in the fellow eye of Japanese patients with unilateral neovascular age-related macular degeneration (AMD).
Basic objectives2
Others
Basic objectives -Others
The 5-year study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between microperimetry and FAF imaging.
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The eligible patients were Japanese, aged over 50 years, and had unilateral neovascular AMD. The inclusion criterion was hyper- or hypofluorescence on FAF imaging in the fellow eye in unilateral neovascular AMD.
Key exclusion criteria
The major exclusion criteria were the presence of exudative findings, including CNV, hemorrhage, serous RPE detachment, serous retinal detachment, and hard exudates, diabetic retinopathy, uveitis, high myopia (less than minus 8.0 diopters), retinal vein occlusion, hazy media interfering with fundus examinations, or a history of laser photocoagulation.
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81-52-853-8251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81-52-853-8251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Santen Pharmaceutical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University School of Medicine
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
+81-52-853-8251
yasukawa@med.nagoya-cu.ac.jp
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
名古屋市立大学病院、九州大学病院、駿河台日本大学病院、福島県立医大病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 22 | 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
67
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
Completed
Date of protocol fixation
| 2006 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2006 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043372
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
