UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055627 |
|---|---|
| Receipt number | R000063445 |
| Scientific Title | Prospective natural follow-up study of inherited retinal diseases. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/26 09:34:58 |
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Basic information
Public title
Prospective natural follow-up study of inherited retinal diseases.
Acronym
Prospective natural follow-up study of inherited retinal diseases.
Scientific Title
Prospective natural follow-up study of inherited retinal diseases.
Scientific Title:Acronym
Prospective natural follow-up study of inherited retinal diseases.
Region
| Japan |
Condition
Condition
Inherited retinal dystrophy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish appropriate evaluation criteria and evaluation periods for future therapeutic interventions for inherited retinal dystrophy.
Basic objectives2
Others
Basic objectives -Others
To identify the progression, visual function prognosis, severity, and those that affect these factors, such as exposure/predictive factors, potential confounders, and effect modifiers in the natural course of inherited retinal dystrophy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function[best corrected visual acuity, visual field (Humphrey visual field 10-2, Microperimeter-3, Goldmann perimetry)]
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have visited Nagoya University Hospital or a collaborative research institution and have been diagnosed with inherited retinal dystrophy and whose causative gene has been identified.
Key exclusion criteria
Patients whose attending physician has judged them to be unsuitable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Kominami |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
4668560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
kominami.taro.p4@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Kominami |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
4668560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
Homepage URL
kominami.taro.p4@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Nagoya University Graduate School of Medicine
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
iga-shinsa@t.mail.nagoya-u.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
| 2024 | Year | 10 | 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
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Through this research, we may be able to obtain detailed information about the prognosis and risk of complications of the disease by gaining knowledge about the natural course and progression mechanisms of hereditary retinal diseases. In addition, gene therapy research is currently progressing rapidly, and by accumulating information about the natural course and influencing factors obtained through this research, we hope to provide a valuable foundation for the realization of future gene therapy.
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | 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=R000063445
