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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013051
Receipt No. R000013995
Scientific Title Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Date of disclosure of the study information 2014/03/01
Last modified on 2019/01/25

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Basic information
Public title Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Acronym Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment
Scientific Title Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Scientific Title:Acronym Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment
Region
Japan

Condition
Condition rhegmatogenous retinal detachment
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of topical Isopropyl Unoprostone for the recovery of photoreceptors after vitrectomy for rhegmatogenous retinal detachment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Best-corrected visual acuity
Key secondary outcomes retinal sensitivity
thickness of outer nuclear layer
macular volume
fundus auto fluorescence
VFQ-25
color sense

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Unoprostone eye drops 0.15%
Interventions/Control_2 placebo eye drops
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria macula-off rhegmatogenous retinal detachment
best-corrected visual acuity <0.3
duration of macula-off retinal detachment < 1week
after successful vitrectomy

Key exclusion criteria severe cataract
macular disease including pathologic myopia
past history of retinal detachment
past history of intraocular surgery
glaucoma, neuropathy
allegy to Unoprostone
past history of topical Unoprostone
pregnancy, breast feeding
severe cardiovascular disease, renal feilure,
uncontrolled diabetes
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Baba
Organization Chiba University Graduate School of Medicine
Division name Ophthalmology and Visual Science
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email babatakayuki@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Baba
Organization Chiba University Graduate School of Medicine
Division name Ophthalmology and Visual Science
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email babatakayuki@nifty.com

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization R-tec Ueno
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 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 Completed
Date of protocol fixation
2014 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2017 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 03 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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