UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050605 |
|---|---|
| Receipt number | R000057591 |
| Scientific Title | Analysis of imaging biomarkers in development and growth of geographic atrophy in Japanese with dry aged macular degeneration |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2024/03/15 09:09:21 |
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Basic information
Public title
Analysis of imaging biomarkers in development and growth of
geographic atrophy in Japanese with dry aged macular degeneration
Acronym
Japanese dry Age-related Macular degeneration Observational study
(JAMO)
Scientific Title
Analysis of imaging biomarkers in development and growth of
geographic atrophy in Japanese with dry aged macular degeneration
Scientific Title:Acronym
Japanese dry Age-related Macular degeneration Observational study
(JAMO)
Region
| Japan |
Condition
Condition
dry age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing dry age-related macular degeneration images and analyzing imaging biomarkers in the onset and growth of Japanese people
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atrophic progress speed
Key secondary outcomes
Sex, age, eyesight, refraction, ocular tension, the axis oculi head, findings, medical history
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
| 55 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A boundary region of GA secondary to AMD being good in at least one eye, and there not being findings of choroid neovascularity (CNV) of the past or the activity.
When GA is multiple, at least one GA area must exceed 250micrometre in diameter.
Key exclusion criteria
There are the atrophy findings of either eye by the cause except AMD.
(e.g., single hereditary macular dystrophy [case: stargardt disease, cone dystrophy] or toxic maculopathy of retina [case: chloroquine/hydroxychloroquine maculopathy])
Participating in a trial of GA or dry AMD,and being treated with the investigational new drug.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
0285-58-7382
akahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
0285-58-7382
Homepage URL
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-7550
rinri@jichi.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 | 03 | Month | 15 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We intend for 40 patients in accordance with eligibility criteria in the patients who consulted our institution by December 31, 2023 from January 1, 2014.
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
