UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052309 |
|---|---|
| Receipt number | R000051524 |
| Scientific Title | Macular Atrophy Clinical Study |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2023/09/26 06:33:01 |
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Basic information
Public title
Macular Atrophy Clinical Study
Acronym
MACS
Scientific Title
Macular Atrophy Clinical Study
Scientific Title:Acronym
MACS
Region
| Japan |
Condition
Condition
Retinal Diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze the characteristics of the macular atrophy including dry type age-related macular degeneration to understand the pathogenesis, in particular, in Japanese patients. This is an observational study.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anatomical characteristics of the macular atrophy
Key secondary outcomes
Relationship between anatomical characteristics of the macular atrophy and results of the interview and past histories, and changes in the clinical findings over time
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients who have macular atrophy
Key exclusion criteria
Those who do not agree to join the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjukuku Tokyo Japan
TEL
+8133531211
ozaway@luke.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-0007
Address
35 Shinanomachi Shinjukuku Tokyo Japan
TEL
+8133531211
Homepage URL
ozawa@a5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokushima Univ Mie Univ Nagoya City Uni Kagoshima Univ Nara Medical Univ Sapporo Hospital Kobe Univ Shinshu Univ Hyogo Univ
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keiol University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjukuku Tokyo Japan
Tel
+8133531211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze results of interview, eye exams, and blood pressure in a cross-sectional and over time manners.
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051524
