UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Title of the study (Brief title)	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	Takayuki Baba
Organization	Chiba University Graduate School of Medicine
Division name	Ophthalmology and Visual Science
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email	babatakayuki@nifty.com

Public contact
Name of contact person	Takayuki Baba
Organization	Chiba University Graduate School of Medicine
Division name	Ophthalmology and Visual Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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