UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039657
Receipt number R000045174
Scientific Title Natural history study of Bietti Crystalline dystrophy
Date of disclosure of the study information 2020/04/01
Last modified on 2022/09/05 08:38:47

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Basic information

Public title

Natural history study of Bietti Crystalline dystrophy

Acronym

Prog Crystalline

Scientific Title

Natural history study of Bietti Crystalline dystrophy

Scientific Title:Acronym

Prog Crystalline

Region

Japan


Condition

Condition

Bietti crystalline dystrophy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate detailed natural history of the Bietti crystalline dystrophy.

Basic objectives2

Others

Basic objectives -Others

To estimate the required sample size for future clinical trials. In addition, the data can be used as a progression speed of control group.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of mean deviation measured with Humphrey visual field analyzer 10-2 program.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Clinical diagnosis of Bietti crystalline dystrophy and biallelic mutations in CYP4V2 gene.

Key exclusion criteria

Emery-Little grade >= 3 or subposterior capsular opacity cataract.
Any retinal or optic nerve disease other than Bietti crystalline dystrophy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akio
Middle name
Last name Oishi

Organization

Kyoto University

Division name

Department of Ophthalmology

Zip code

606-8507

Address

54, Shogoin Kawaharacho

TEL

0757513250

Email

aquio@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Akio
Middle name
Last name Oishi

Organization

Kyoto University

Division name

Department of Ophthalmology

Zip code

606-8507

Address

54, Shogoin Kawaharacho

TEL

0757513250

Homepage URL


Email

aquio@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for 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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54, Shogoin Kawaharacho

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

京都大学(京都府)、名古屋大学(愛知県)、九州大学(福岡県)、東京慈恵会医科大学(東京都)、東京医療センター(東京都)、長崎大学(長崎県)


Other administrative information

Date of disclosure of the study information

2020 Year 04 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

14

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

2020 Year 02 Month 29 Day

Date of IRB

2020 Year 04 Month 08 Day

Anticipated trial start date

2020 Year 04 Month 08 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects are followed every six months. Visual acuity, visual field, fundus photograph, fundus autofluorescence, near infrared reflectance, optical coherence tomography are measured at each visit.


Management information

Registered date

2020 Year 03 Month 02 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name