UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006820 |
|---|---|
| Receipt number | R000008065 |
| Scientific Title | Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa |
| Date of disclosure of the study information | 2011/12/02 |
| Last modified on | 2012/12/08 11:32:14 |
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Basic information
Public title
Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa
Acronym
Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa
Scientific Title
Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa
Scientific Title:Acronym
Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the neuroprotective effect of topical unoprostone isopropyl or nipradilol on patients with retinitis pigmentosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of the treatment was monitored by the following parameters before and after treatment (6 months or 12 months).
(1) best corrected visual acuity
(2) visual field measurement testing using the Humphrey Field Analyzer (HFA: the central 10-2 Program)
(3) retinal sensitivity measurement using microperimeter (MP-1)
(4) retinal circulation measurement using Laser Speckle flowgrafy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.12% topical unoprostone isopropyl twice daily
Interventions/Control_2
0.25% topical nipradilol twice daily
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
(1) patients with retinitis pigmentosa
(2) BCVA >= 0.1
(3) patinets whose agreement was shown by him/herself
Key exclusion criteria
(1) a past history of glaucoma or ocular hypertension
(2) patients with another macular disorder, such as epiretinal membrane
(3) a past history of using the test drug within 6 months
(4) pregnant subjects, subjects suspected of being pregnant, or breast-feeding subjects
(5) hypersensitivity to the test drug
(6) a past history of the entry into another clinical trial within 1 year
(7) inappropriate case judged by investigator or subinvestigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishibashi |
Organization
Kyushu university hospital
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyushu university hospital
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2011 | Year | 12 | Month | 02 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 02 | Day |
Last modified on
| 2012 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008065
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
